Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| AVF4124s | |||
| 9597-07-4R0 | Other Identifier | Duke IRB Legacy Number |
Not provided
Not provided
Not provided
Slow accrual
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Our hypothesis is that this study design, in which bevacizumab is added to one of six single agent chemotherapies with proven activity in metastatic breast cancer, will result in regression or stabilization of this disease in a safe and tolerable manner.
There is an unmet clinical need for effective therapy of breast cancer that has metastasized to the brain. In this scenario, median survival is around 12 months using currently available therapeutic interventions. The majority of chemotherapy-based clinical trials have considered the presence of central nervous system metastasis an exclusion criterion due to the risk of toxicities, the inability of chemotherapeutic agents to cross the blood brain barrier, and the limited overall survival within this patient population.
The preclinical data regarding the safety and activity of bevacizumab in vascular endothelial growth factor(VEGF)-expressing tumors provide a good rationale for its study in patients with breast cancer with metastasis to the brain. Yano, et al. illustrated that tumor cell expression of VEGF messenger ribonucleic acid and protein directly correlated with angiogenesis and growth of brain metastasis in a nude mouse model. Transfecting the experimental cell lines known to produce visceral metastasis with an anti-sense VEGF-gene significantly reduced the incidence of brain metastasis. Kim, et al. illustrated that a murine model specific for brain metastases originating from breast cancer showed elevated expression of the angiogenic and permeability-inducing factor VEGF-A. The growth of the brain metastases in this model was attenuated by the addition of a VEGF-tyrosine kinase inhibitor via induction of apoptosis and decreased angiogenesis. VEGF has also been implicated in the development of brain edema, a significant source of the morbidity and mortality associated with brain metastasis. Enhanced levels of VEGF and its receptors have been reported in a murine model after induction of cortical ischemia. Finally, antagonism of VEGF was demonstrated to reduce both immediate and delayed volume of infarct.
The optimal dose of bevacizumab has been extensively studied in phase I trials alone and in combination with chemotherapy. The safe and effective dose has been established as 10 mg/kg q 14 days or 15 mg/kg Q 21 days. In addition to irinotecan and paclitaxel, it has been previously used in phase II/III settings in combination with capecitabine, vinorelbine, gemcitabine, and docetaxel. Phase III studies showed an overall survival advantage when bevacizumab was added to an irinotecan/Fluorouracil (5FU)-based regimen for metastatic colorectal cancer, and when added to weekly paclitaxel for metastatic breast cancer.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab / Capecitabine | Active Comparator | Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle. |
|
| Bevacizumab / Docetaxel | Active Comparator | Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. |
|
| Bevacizumab /Irinotecan (Camptosar®, CPT-11) | Active Comparator | CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. |
|
| Bevacizumab / Paclitaxel | Active Comparator | Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. |
|
| Bevacizumab /Vinorelbine Tartrate | Active Comparator | Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab(Avastin) 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle. until progression or unacceptable toxicity develops |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 3.0) Toxicity Reporting Criteria. | Primary endpoint has not been analysed secondary to slow and low accrual numbers. | May 2009 |
| Determining the Safety and Tolerability of Adding Avastin to Single Agent Chemotherapy to Treat Patients With Brain Metastasis Originating From Breast Cancer | Due to slow accrual study was prematurely closed and endpoint not analysed | trial closure |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Activity of Avastin When Added to Single Agent Chemotherapy, as Measured by Radiographic Response Rate,Progression Free Survival, and Overall Survival. | Due to slow accrual study was prematurely closed and endpoint not analysed | 8 to 9 weeks |
| To Assess the Quality of Life During Treatment With This Therapeutic Approach |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kimberly Blackwell, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palm Beach Cancer Center Institute | West Palm Beach | Florida | 33401-3406 | United States | ||
| Presbyterian Health Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16001989 | Background | Kirsch DG, Loeffler JS. Brain metastases in patients with breast cancer: new horizons. Clin Breast Cancer. 2005 Jun;6(2):115-24. doi: 10.3816/CBC.2005.n.013. | |
| 8509821 | Background | Boogerd W, Vos VW, Hart AA, Baris G. Brain metastases in breast cancer; natural history, prognostic factors and outcome. J Neurooncol. 1993 Feb;15(2):165-74. doi: 10.1007/BF01053937. |
Not provided
Not provided
to meet inclusion must be 2 wks from prior hormonal chemotherapy and radio-static surgery, 4 weeks since major surgery and 8 weeks from neuro surgery. excluded for prior tx with avastin or other anti-angiogenic therapy. Central Nervous system hemorrhage
Subjects will be identified in cancer center outpatient clinics multi-site. The study will be introduced by a physician or caregiver known to the patient. We will need to review protected health information in order to identify subjects, and information resulting from this activity will be used only to assess eligibility of a subject.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab / Capecitabine | Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle. |
| FG001 | Bevacizumab / Docetaxel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Bevacizumab / Gemcitabine | Active Comparator | Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle. |
|
|
| Docetaxel | Drug | Docetaxel 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. until progression or unacceptable toxicity develops |
|
|
| CPT-11 | Drug | CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.until progression or unacceptable toxicity develops |
|
|
| Paclitaxel | Drug | Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.until progression or unacceptable toxicity develops |
|
|
| Vinorelbine Tartrate | Drug | Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle. until progression or unacceptable toxicity develops |
|
|
| Gemcitabine | Drug | Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.until progression or unacceptable toxicity develops |
|
|
Due to slow accrual study was prematurely closed and endpoint not analysed |
| 8 to 9 weeks |
| Charlotte |
| North Carolina |
| 28204 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Virginia Oncology Associates | Newport News | Virginia | 23606 | United States |
| 15337811 | Background | Lin NU, Bellon JR, Winer EP. CNS metastases in breast cancer. J Clin Oncol. 2004 Sep 1;22(17):3608-17. doi: 10.1200/JCO.2004.01.175. |
| 9128946 | Background | Gaspar L, Scott C, Rotman M, Asbell S, Phillips T, Wasserman T, McKenna WG, Byhardt R. Recursive partitioning analysis (RPA) of prognostic factors in three Radiation Therapy Oncology Group (RTOG) brain metastases trials. Int J Radiat Oncol Biol Phys. 1997 Mar 1;37(4):745-51. doi: 10.1016/s0360-3016(96)00619-0. |
| 12654426 | Background | Engel J, Eckel R, Aydemir U, Aydemir S, Kerr J, Schlesinger-Raab A, Dirschedl P, Holzel D. Determinants and prognoses of locoregional and distant progression in breast cancer. Int J Radiat Oncol Biol Phys. 2003 Apr 1;55(5):1186-95. doi: 10.1016/s0360-3016(02)04476-0. |
| 2405271 | Background | Patchell RA, Tibbs PA, Walsh JW, Dempsey RJ, Maruyama Y, Kryscio RJ, Markesbery WR, Macdonald JS, Young B. A randomized trial of surgery in the treatment of single metastases to the brain. N Engl J Med. 1990 Feb 22;322(8):494-500. doi: 10.1056/NEJM199002223220802. |
| 11261830 | Background | Lederman G, Wronski M, Fine M. Fractionated radiosurgery for brain metastases in 43 patients with breast carcinoma. Breast Cancer Res Treat. 2001 Jan;65(2):145-54. doi: 10.1023/a:1006490200335. |
| 10864339 | Background | Firlik KS, Kondziolka D, Flickinger JC, Lunsford LD. Stereotactic radiosurgery for brain metastases from breast cancer. Ann Surg Oncol. 2000 Jun;7(5):333-8. doi: 10.1007/s10434-000-0333-1. |
| 4938153 | Background | Folkman J. Tumor angiogenesis: therapeutic implications. N Engl J Med. 1971 Nov 18;285(21):1182-6. doi: 10.1056/NEJM197111182852108. No abstract available. |
| 12778165 | Background | Ferrara N, Gerber HP, LeCouter J. The biology of VEGF and its receptors. Nat Med. 2003 Jun;9(6):669-76. doi: 10.1038/nm0603-669. |
| 7664263 | Background | Takahashi Y, Kitadai Y, Bucana CD, Cleary KR, Ellis LM. Expression of vascular endothelial growth factor and its receptor, KDR, correlates with vascularity, metastasis, and proliferation of human colon cancer. Cancer Res. 1995 Sep 15;55(18):3964-8. |
| 7821921 | Background | Brown LF, Berse B, Jackman RW, Tognazzi K, Guidi AJ, Dvorak HF, Senger DR, Connolly JL, Schnitt SJ. Expression of vascular permeability factor (vascular endothelial growth factor) and its receptors in breast cancer. Hum Pathol. 1995 Jan;26(1):86-91. doi: 10.1016/0046-8177(95)90119-1. |
| 12853836 | Background | Na X, Wu G, Ryan CK, Schoen SR, di'Santagnese PA, Messing EM. Overproduction of vascular endothelial growth factor related to von Hippel-Lindau tumor suppressor gene mutations and hypoxia-inducible factor-1 alpha expression in renal cell carcinomas. J Urol. 2003 Aug;170(2 Pt 1):588-92. doi: 10.1097/01.ju.0000074870.54671.98. |
| 7472781 | Background | Fontanini G, Bigini D, Vignati S, Basolo F, Mussi A, Lucchi M, Chine S, Angeletti CA, Harris AL, Bevilacqua G. Microvessel count predicts metastatic disease and survival in non-small cell lung cancer. J Pathol. 1995 Sep;177(1):57-63. doi: 10.1002/path.1711770110. |
| 15755986 | Background | Schneider BP, Miller KD. Angiogenesis of breast cancer. J Clin Oncol. 2005 Mar 10;23(8):1782-90. doi: 10.1200/JCO.2005.12.017. No abstract available. |
| 9041202 | Background | Relf M, LeJeune S, Scott PA, Fox S, Smith K, Leek R, Moghaddam A, Whitehouse R, Bicknell R, Harris AL. Expression of the angiogenic factors vascular endothelial cell growth factor, acidic and basic fibroblast growth factor, tumor growth factor beta-1, platelet-derived endothelial cell growth factor, placenta growth factor, and pleiotrophin in human primary breast cancer and its relation to angiogenesis. Cancer Res. 1997 Mar 1;57(5):963-9. |
| 10469350 | Background | Ferrara N. Role of vascular endothelial growth factor in the regulation of angiogenesis. Kidney Int. 1999 Sep;56(3):794-814. doi: 10.1046/j.1523-1755.1999.00610.x. |
| 15175435 | Background | Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691. |
| Background | Miller KD, et al. E2100: a randomized phase III trial of paclitaxel vs paclitaxel plus bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer. Proc: ASCO 2005; (#3) (Abstract). |
| 10987313 | Background | Yano S, Shinohara H, Herbst RS, Kuniyasu H, Bucana CD, Ellis LM, Davis DW, McConkey DJ, Fidler IJ. Expression of vascular endothelial growth factor is necessary but not sufficient for production and growth of brain metastasis. Cancer Res. 2000 Sep 1;60(17):4959-67. |
| 12777082 | Background | Salmaggi A, Eoli M, Frigerio S, Silvani A, Gelati M, Corsini E, Broggi G, Boiardi A. Intracavitary VEGF, bFGF, IL-8, IL-12 levels in primary and recurrent malignant glioma. J Neurooncol. 2003 May;62(3):297-303. doi: 10.1023/a:1023367223575. |
| 15168728 | Background | Kim LS, Huang S, Lu W, Lev DC, Price JE. Vascular endothelial growth factor expression promotes the growth of breast cancer brain metastases in nude mice. Clin Exp Metastasis. 2004;21(2):107-18. doi: 10.1023/b:clin.0000024761.00373.55. |
| 12684411 | Background | Lamszus K, Ulbricht U, Matschke J, Brockmann MA, Fillbrandt R, Westphal M. Levels of soluble vascular endothelial growth factor (VEGF) receptor 1 in astrocytic tumors and its relation to malignancy, vascularity, and VEGF-A. Clin Cancer Res. 2003 Apr;9(4):1399-405. |
| 14583454 | Background | Godard S, Getz G, Delorenzi M, Farmer P, Kobayashi H, Desbaillets I, Nozaki M, Diserens AC, Hamou MF, Dietrich PY, Regli L, Janzer RC, Bucher P, Stupp R, de Tribolet N, Domany E, Hegi ME. Classification of human astrocytic gliomas on the basis of gene expression: a correlated group of genes with angiogenic activity emerges as a strong predictor of subtypes. Cancer Res. 2003 Oct 15;63(20):6613-25. |
| 12744467 | Background | Birner P, Piribauer M, Fischer I, Gatterbauer B, Marosi C, Ambros PF, Ambros IM, Bredel M, Oberhuber G, Rossler K, Budka H, Harris AL, Hainfellner JA. Vascular patterns in glioblastoma influence clinical outcome and associate with variable expression of angiogenic proteins: evidence for distinct angiogenic subtypes. Brain Pathol. 2003 Apr;13(2):133-43. doi: 10.1111/j.1750-3639.2003.tb00013.x. |
| 11817706 | Background | Stefanik DF, Fellows WK, Rizkalla LR, Rizkalla WM, Stefanik PP, Deleo AB, Welch WC. Monoclonal antibodies to vascular endothelial growth factor (VEGF) and the VEGF receptor, FLT-1, inhibit the growth of C6 glioma in a mouse xenograft. J Neurooncol. 2001 Nov;55(2):91-100. doi: 10.1023/a:1013329832067. |
| 14613032 | Background | Cobleigh MA, Langmuir VK, Sledge GW, Miller KD, Haney L, Novotny WF, Reimann JD, Vassel A. A phase I/II dose-escalation trial of bevacizumab in previously treated metastatic breast cancer. Semin Oncol. 2003 Oct;30(5 Suppl 16):117-24. doi: 10.1053/j.seminoncol.2003.08.013. |
| Background | Vrendenburgh JJ, et al. Bevacizumab, a monoclonal antibody to VEGF, and irinotecan for the treatment of malignant gliomas. Proc: ASCO 2006;24(18S):1506. |
| 10587525 | Background | van Bruggen N, Thibodeaux H, Palmer JT, Lee WP, Fu L, Cairns B, Tumas D, Gerlai R, Williams SP, van Lookeren Campagne M, Ferrara N. VEGF antagonism reduces edema formation and tissue damage after ischemia/reperfusion injury in the mouse brain. J Clin Invest. 1999 Dec;104(11):1613-20. doi: 10.1172/JCI8218. |
| 8841346 | Background | Kovacs Z, Ikezaki K, Samoto K, Inamura T, Fukui M. VEGF and flt. Expression time kinetics in rat brain infarct. Stroke. 1996 Oct;27(10):1865-72; discussion 1872-3. doi: 10.1161/01.str.27.10.1865. |
| 15681523 | Background | Miller KD, Chap LI, Holmes FA, Cobleigh MA, Marcom PK, Fehrenbacher L, Dickler M, Overmoyer BA, Reimann JD, Sing AP, Langmuir V, Rugo HS. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol. 2005 Feb 1;23(4):792-9. doi: 10.1200/JCO.2005.05.098. |
| Background | Burstin HJ, et al. Phase II trial of anti-VEGF antibody bevacizumab in combination with vinorelbine for refractory advanced breast cancer. Breast Can Res Treat 2002;76(supp 1):S115. |
| 16258101 | Background | Kindler HL, Friberg G, Singh DA, Locker G, Nattam S, Kozloff M, Taber DA, Karrison T, Dachman A, Stadler WM, Vokes EE. Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2005 Nov 1;23(31):8033-40. doi: 10.1200/JCO.2005.01.9661. |
| 16707611 | Background | Ramaswamy B, Elias AD, Kelbick NT, Dodley A, Morrow M, Hauger M, Allen J, Rhoades C, Kendra K, Chen HX, Eckhardt SG, Shapiro CL. Phase II trial of bevacizumab in combination with weekly docetaxel in metastatic breast cancer patients. Clin Cancer Res. 2006 May 15;12(10):3124-9. doi: 10.1158/1078-0432.CCR-05-2603. |
| Background | Genentech, Inc. Investigator's Brochure. Issued April 2006. |
| 2358840 | Background | Macdonald DR, Cascino TL, Schold SC Jr, Cairncross JG. Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol. 1990 Jul;8(7):1277-80. doi: 10.1200/JCO.1990.8.7.1277. |
| 14755389 | Background | Jung SH, Lee T, Kim K, George SL. Admissible two-stage designs for phase II cancer clinical trials. Stat Med. 2004 Feb 28;23(4):561-9. doi: 10.1002/sim.1600. |
| Background | Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Amer Stat Assoc 1958;43:457-81. |
Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
| FG002 | Bevacizumab / Irinotecan (Camptosar®, CPT-11) | CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. |
| FG003 | Bevacizumab / Paclitaxel | Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. |
| FG004 | Bevacizumab /Vinorelbine Tartrate | Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle. |
| FG005 | Bevacizumab / Gemcitabine | Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab / Capecitabine | Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle. |
| BG001 | Bevacizumab / Docetaxel | Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. |
| BG002 | Bevacizumab / CPT-11 | CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. |
| BG003 | Bevacizumab / Paclitaxel | Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. |
| BG004 | Bevacizumab /Vinorelbine Tartrate | Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle. |
| BG005 | Bevacizumab / Gemcitabine | Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Number | participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 3.0) Toxicity Reporting Criteria. | Primary endpoint has not been analysed secondary to slow and low accrual numbers. | Endpoint has not been analysed secondary to slow and low accrual numbers. | Posted | May 2009 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Assess the Activity of Avastin When Added to Single Agent Chemotherapy, as Measured by Radiographic Response Rate,Progression Free Survival, and Overall Survival. | Due to slow accrual study was prematurely closed and endpoint not analysed | Due to slow accrual study was prematurely closed and endpoint not analysed | Posted | 8 to 9 weeks |
| |||||||||||||||||||||||||||||||||||
| Primary | Determining the Safety and Tolerability of Adding Avastin to Single Agent Chemotherapy to Treat Patients With Brain Metastasis Originating From Breast Cancer | Due to slow accrual study was prematurely closed and endpoint not analysed | Due to slow accrual study was prematurely closed and endpoint not analysed | Posted | trial closure |
| |||||||||||||||||||||||||||||||||||
| Secondary | To Assess the Quality of Life During Treatment With This Therapeutic Approach | Due to slow accrual study was prematurely closed and endpoint not analysed | Posted | 8 to 9 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avastin (Bevacizumab)/ Capecitabine (Xeloda) | 2 | 3 | 3 | 3 | |||
| EG001 | Avastin (Bevacizumab) / Camptosar (CPT 11/ Irinotecan) | 1 | 1 | 1 | 1 | |||
| EG002 | Avastin (Bevacizumab)/Gemzar(Gemcitabine,Difluorodeoxycytidine | 1 | 2 | 2 | 2 | |||
| EG003 | Avastin (Bevacizumab)/Navelbine (Vinorelbine Tartrate) | 0 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | grade 3, Xeloda/Avastin arm |
|
| renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypophophatemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| hypokalemia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT: increased | Hepatobiliary disorders | ctc3 |
| ||
| anemia | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| anorexia | General disorders | CTCAE (3.0) |
| ||
| AST: elevated | Hepatobiliary disorders | CTCAE (3.0) |
| ||
| Ataxia | Nervous system disorders | CTCAE (3.0) |
| ||
| Calcium: elevated | Investigations | CTCAE (3.0) |
| ||
| heart flutter | Cardiac disorders | CTCAE (3.0) |
| ||
| constipation | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| Anxiety | Psychiatric disorders | CTCAE (3.0) |
| ||
| mouth tenderness | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| Creatinine:elevated | Investigations | CTCAE (3.0) |
| ||
| dehydration | General disorders | CTCAE (3.0) |
| ||
| dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| diarrhea | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| dizziness | Nervous system disorders | CTCAE (3.0) |
| ||
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
| ||
| edema: limb | General disorders | CTCAE (3.0) |
| ||
| fatigue | General disorders | CTCAE (3.0) |
| ||
| Flushing | General disorders | CTCAE (3.0) |
| ||
| hair loss | General disorders | CTCAE (3.0) |
| ||
| heart burn | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| hemaglobin | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| nose bleeds | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| hot flashes | Reproductive system and breast disorders | CTCAE (3.0) |
| ||
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
| ||
| Insomnia | General disorders | CTCAE (3.0) |
| ||
| leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) |
| ||
| libido | Reproductive system and breast disorders | CTCAE (3.0) |
| ||
| memory impairment | Psychiatric disorders | CTCAE (3.0) |
| ||
| hypokalemia | Investigations | CTCAE (3.0) |
| ||
| irritability | Psychiatric disorders | CTCAE (3.0) |
| ||
| depression | Psychiatric disorders | CTCAE (3.0) |
| ||
| stomatitis | Skin and subcutaneous tissue disorders |
| |||
| muscle weakness | Musculoskeletal and connective tissue disorders |
| |||
| nausea | Gastrointestinal disorders | CTCAE (3.0) |
| ||
| neuropathy sensory | Nervous system disorders |
| |||
| neutrophils | Blood and lymphatic system disorders |
| |||
| peripheral vision changes | Eye disorders |
| |||
| blindness | Eye disorders |
| |||
| Pain: shingles | General disorders |
| |||
| Pain: Shoulder and back | General disorders |
| |||
| Pain: breast | General disorders |
| |||
| Pain: extremity | Musculoskeletal and connective tissue disorders |
| |||
| headache | Nervous system disorders |
| |||
| blurred vision | Eye disorders |
| |||
| visual floaters | Eye disorders |
| |||
| voice changes | General disorders |
| |||
| vomiting | Gastrointestinal disorders |
| |||
| weight gain | Gastrointestinal disorders |
| |||
| joint pain | Musculoskeletal and connective tissue disorders |
| |||
| phosphorus low | Investigations |
| |||
| sore throat | General disorders |
| |||
| rash | Skin and subcutaneous tissue disorders |
| |||
| hand foot syndrome | Skin and subcutaneous tissue disorders |
| |||
| renal failure | Renal and urinary disorders |
| |||
| chills/rigors | General disorders |
| |||
| seizure | Nervous system disorders |
| |||
| skin breakdown | Skin and subcutaneous tissue disorders |
| |||
| taste changes | Gastrointestinal disorders |
| |||
| cerebral thrombosis | Nervous system disorders |
| |||
| DVT | Blood and lymphatic system disorders |
| |||
| tinnitus | Ear and labyrinth disorders |
| |||
| tremors | Nervous system disorders |
| |||
| BUN elevated | Investigations |
| |||
| vaginal dryness | Reproductive system and breast disorders |
| |||
| weight loss | General disorders |
| |||
| dry mouth | Skin and subcutaneous tissue disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Blackwell, MD | Duke University | 919-668-1748 | kimberly.blackwell@duke.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077143 | Docetaxel |
| D000077146 | Irinotecan |
| D017239 | Paclitaxel |
| D000077235 | Vinorelbine |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle. |
| OG004 | Bevacizumab /Vinorelbine Tartrate | Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle. |
| OG005 | Bevacizumab / Gemcitabine | Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle. |
|
Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
| OG004 | Bevacizumab /Vinorelbine Tartrate | Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle. |
| OG005 | Bevacizumab / Gemcitabine | Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle. |
|
| OG004 | Bevacizumab /Vinorelbine Tartrate | Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle. |
| OG005 | Bevacizumab / Gemcitabine | Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle. |
|