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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00140 | Other Identifier | CTRP (Clinical Trial Reporting Program) | |
| 0504007857 | Other Identifier | Montefiore Medical Center - Moses Campus | |
| 7229 | Other Identifier | CTEP | |
| N01CM62204 | U.S. NIH Grant/Contract | View source | |
| P30CA013330 | U.S. NIH Grant/Contract | View source |
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This trial is studying the side effects and best dose of ixabepilone when given together with pegylated liposomal doxorubicin hydrochloride and to see how well they work in treating women with advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or metastatic breast cancer. Drugs used in chemotherapy, such as ixabepilone and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose and recommended phase II dose of ixabepilone when combined with pegylated doxorubicin hydrochloride (HCl) liposome (pegylated liposomal doxorubicin hydrochloride) in women with previously treated advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or metastatic breast cancer.
II. To determine the safety profile of this regimen in these patients. III. To determine the clinical efficacy of this regimen in patients with platinum- and taxane-resistant advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.
OUTLINE: This is a phase I, multicenter, open-label, dose-escalation study of ixabepilone followed by a phase II study.
Patients receive ixabepilone intravenously (IV) over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. Courses repeat every 21-28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (ixabepilone and doxorubicin) | Experimental | Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ixabepilone | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-limiting Toxicity (DLT), Graded Using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4.0 (Phase I) | Dose-Limiting Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events classification and usually encompasses all grade 3 or higher toxicities | 28 days |
| Maximum Tolerated Dose | The phase I component of the study included 30 patients with breast and ovarian cancer. A protocol amendment was made during phase I trial from a treatment regimen of Schedule A (ixabepilone every 3-4 weeks) to Schedule B (ixabepilone every week). The maximum tolerated dose was determined to be the preceding dose of any dose that resulted in 2 DLT events. Schedule B was carried forward to the phase II trial. The Maximum Tolerated Dose for Schedule B is reported. Please see (Chuang et al., 2010) for additional details | Once 2 DLT events occur in patients during the first 28 days of treatment (cycle 1), the preceding dose will be designated the maximum tolerated dose (MTD). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Responding to Therapy (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]), Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) and Cancer Antigen-125 (CA-125) Response Criteria (Phase II) | Up to 2 years | |
| Progression-free Survival |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Chuang | Montefiore Medical Center - Moses Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut | Farmington | Connecticut | 06030 | United States | ||
| Women's Cancer Care Associates LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20357034 | Result | Chuang E, Wiener N, Christos P, Kessler R, Cobham M, Donovan D, Goldberg GL, Caputo T, Doyle A, Vahdat L, Sparano JA. Phase I trial of ixabepilone plus pegylated liposomal doxorubicin in patients with adenocarcinoma of breast or ovary. Ann Oncol. 2010 Oct;21(10):2075-2080. doi: 10.1093/annonc/mdq080. Epub 2010 Mar 31. |
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A total of 45 patients were enrolled and treated between January 2006 and May 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixabepilone: 24mg/m2 and Doxil 30 mg/m2: Level 1 | Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. ixabepilone: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV |
| FG001 | Ixabepilone: 32mg/m2 and Doxil 30 mg/m2: Level 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| pegylated liposomal doxorubicin hydrochloride | Drug | Given IV |
|
|
We will summarize progression-free survival by Kaplan-Meier survival analysis.
| The time from start of treatment to time of progression or death, assessed up to 2 years |
| Albany |
| New York |
| 12208 |
| United States |
| Weill Medical College of Cornell University | New York | New York | 10065 | United States |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467-2490 | United States |
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. ixabepilone: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV |
| FG002 | Ixabepilone: 40mg/m2 and Doxil 30 mg/m2: Level 3 | Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. ixabepilone: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV |
| FG003 | Ixabepilone: 13mg/m2 and Doxil 30 mg/m2: Level 4 | Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. ixabepilone: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV |
| FG004 | Ixabepilone: 16mg/m2 and Doxil 30 mg/m2: Level 5 | Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. ixabepilone: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Ixabepilone and Doxorubicin) | Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes. ixabepilone: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Incidence of Dose-limiting Toxicity (DLT), Graded Using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4.0 (Phase I) | Dose-Limiting Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events classification and usually encompasses all grade 3 or higher toxicities | Posted | Number | participants | 28 days |
|
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| |||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Responding to Therapy (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]), Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) and Cancer Antigen-125 (CA-125) Response Criteria (Phase II) | Posted | Number | participants | Up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | We will summarize progression-free survival by Kaplan-Meier survival analysis. | Posted | Median | 95% Confidence Interval | months | The time from start of treatment to time of progression or death, assessed up to 2 years |
|
| |||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Tolerated Dose | The phase I component of the study included 30 patients with breast and ovarian cancer. A protocol amendment was made during phase I trial from a treatment regimen of Schedule A (ixabepilone every 3-4 weeks) to Schedule B (ixabepilone every week). The maximum tolerated dose was determined to be the preceding dose of any dose that resulted in 2 DLT events. Schedule B was carried forward to the phase II trial. The Maximum Tolerated Dose for Schedule B is reported. Please see (Chuang et al., 2010) for additional details | The phase I component of the study included 30 patients with breast and ovarian cancer. | Posted | Number | mg/m2 | Once 2 DLT events occur in patients during the first 28 days of treatment (cycle 1), the preceding dose will be designated the maximum tolerated dose (MTD). |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1 | Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. ixabepilone: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV | 6 | 6 | 6 | 6 | ||
| EG001 | Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2 | Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. ixabepilone: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV | 6 | 6 | 6 | 6 | ||
| EG002 | Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3 | Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1. ixabepilone: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV | 6 | 6 | 6 | 6 | ||
| EG003 | Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4 | Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 ixabepilone: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV | 3 | 3 | 3 | 3 | ||
| EG004 | Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5 | Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 ixabepilone: Given IV pegylated liposomal doxorubicin hydrochloride: Given IV | 24 | 24 | 24 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Bilirubin increased | Investigations |
| |||
| CNS cerebrovascular ischemia | Nervous system disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Fatigue | General disorders |
| |||
| Anemia | Blood and lymphatic system disorders |
| |||
| Hemorrhage, pulmonary/upper respiratory | Respiratory, thoracic and mediastinal disorders |
| |||
| Infection with grade 3 or 4 neutrophils | Infections and infestations |
| |||
| White blood cell count decreased | Investigations |
| |||
| Mucositis | Gastrointestinal disorders |
| |||
| Neuropathy: Sensory | Nervous system disorders |
| |||
| Neutrophils count decreased | Investigations |
| |||
| Rash: desquamation | Skin and subcutaneous tissue disorders |
| |||
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Lung infections | Infections and infestations |
| |||
| Headache | Nervous system disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Death NOS | General disorders |
| |||
| Bone pain | Musculoskeletal and connective tissue disorders |
| |||
| Chest Wall Pain | Musculoskeletal and connective tissue disorders |
| |||
| Thromboembolic event | Vascular disorders |
| |||
| Catheter related infection | Infections and infestations |
| |||
| Platelet count decreased | Investigations |
| |||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Dehydration | Gastrointestinal disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Small intestinal obstruction | Gastrointestinal disorders |
| |||
| Hypophosphatemia | Metabolism and nutrition disorders |
| |||
| Hypercalcemia | Metabolism and nutrition disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Ascites | Gastrointestinal disorders |
| |||
| Hot flashes | Vascular disorders |
| |||
| Ataxia | Nervous system disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Anorexia | Gastrointestinal disorders |
| |||
| Rash maculo-papular | Infections and infestations |
| |||
| Soft tissue infection | Infections and infestations |
| |||
| Dyspepsia | Gastrointestinal disorders |
| |||
| Alopecia | Skin and subcutaneous tissue disorders |
| |||
| Hiccups | Respiratory, thoracic and mediastinal disorders |
| |||
| Breast pain | Reproductive system and breast disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Dysgeusia | Nervous system disorders |
| |||
| Peripheral motor neuropathy | Nervous system disorders |
| |||
| Nail loss | Skin and subcutaneous tissue disorders |
| |||
| Blurred vision | Eye disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Fatigue | General disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Neck pain | Musculoskeletal and connective tissue disorders |
| |||
| Myalgia | Musculoskeletal and connective tissue disorders |
| |||
| Abdominal distension | Gastrointestinal disorders |
| |||
| Sinus tachycardia | Cardiac disorders |
| |||
| Platelet count decreased | Investigations |
| |||
| Ascites | Gastrointestinal disorders |
| |||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Fever | General disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Small intestinal obstruction | Gastrointestinal disorders |
| |||
| Creatinine increased | Investigations |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Peripheral sensory neuropathy | Nervous system disorders |
| |||
| Chills | General disorders |
| |||
| Edema limbs | General disorders |
| |||
| Depression | Psychiatric disorders |
| |||
| Sinus disorder | Respiratory, thoracic and mediastinal disorders |
| |||
| Vaginal dryness | Reproductive system and breast disorders |
| |||
| Dry eye | Eye disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Vaginal inflammation | Reproductive system and breast disorders |
| |||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Dysphagia | Gastrointestinal disorders |
| |||
| Mucositis oral | Gastrointestinal disorders |
| |||
| Hand and foot syndrome | Skin and subcutaneous tissue disorders |
| |||
| Anemia | Blood and lymphatic system disorders |
| |||
| Esophagitis | Gastrointestinal disorders |
| |||
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders |
| |||
| Phlebitis | Vascular disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Urinary tract pain | Renal and urinary disorders |
| |||
| Upper respiratory infection | Infections and infestations |
| |||
| Voice alteration | Respiratory, thoracic and mediastinal disorders |
| |||
| skin infection | Infections and infestations |
| |||
| Vaginal hemorrhage | Reproductive system and breast disorders |
| |||
| Ischemia cerebrovascular | Nervous system disorders |
| |||
| Nail infection | Infections and infestations |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Dehydration | Gastrointestinal disorders |
| |||
| Hepatic Pain | Hepatobiliary disorders |
| |||
| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Bone pain | Musculoskeletal and connective tissue disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Palpitations | Cardiac disorders |
| |||
| Hypoglycemia | Metabolism and nutrition disorders |
| |||
| Depression | Psychiatric disorders |
| |||
| Anxiety | Psychiatric disorders |
| |||
| Gait disturbance | General disorders |
| |||
| Dry mouth | Gastrointestinal disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Rash: acneiform | Skin and subcutaneous tissue disorders |
| |||
| Bruising | Injury, poisoning and procedural complications |
| |||
| Dry skin | Skin and subcutaneous tissue disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Escobar-Peralta, Program Manager | Montefiore Medical Center | 718-379-6866 | lescobar@montefiore.org |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D001943 | Breast Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C430592 | ixabepilone |
| C506643 | liposomal doxorubicin |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Ovarian Cancer |
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| Breast Cancer |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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