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| ID | Type | Description | Link |
|---|---|---|---|
| NYU 03-67 | Other Identifier | New York University | |
| N01CM62204 | U.S. NIH Grant/Contract | View source |
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This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as oxaliplatin and topotecan, 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. Estimate the overall clinical response rate (complete and partial responses) in patients with previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with oxaliplatin and topotecan.
II. Determine the toxic effects in patients treated with this regimen.
SECONDARY OBJECTIVES:
I. Estimate the time to progression and overall clinical response duration in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to response to prior platinum therapy (resistant vs sensitive).
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (oxaliplatin plus topotecan) | Experimental | Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxaliplatin | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) | Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR. | Every two cycles for up to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Disease Progression by RECIST and/or CA 125 | Time to disease progression by RECIST and/or CA 125 | Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks |
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Inclusion Criteria:
Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
Meets 1 of the following criteria for response to prior platinum-based therapy:
Measurable or evaluable disease: Measurable disease is characterized as lesions reproducibly measurable in 1 dimension; evaluable disease is defined as known disease with CA125 levels > 50 U/mL on 2 occasions >= 1 week apart
Previously treated with a taxane and platinum-based regimen, only 1 prior platinum-based regimen, including IV or intraperitoneal consolidation, one additional non-platinum and non-topotecan chemotherapy regimen allowed
Life expectancy >= 4 months
Total bilirubin =< 1.5 times upper limit of normal (ULN)
AST =< 2.5 times ULN (5 times ULN if liver metastases are present)
Creatinine =< 1.5 times ULN AND creatinine clearance > 40 mg/dL
Exclusion criteria:
No presence of any other active cancer
No uncontrolled intercurrent illness, including the following:
No history of severe allergy to platinum compounds
No history of allergic reaction to appropriate antiemetics (e.g., 5HT3 antagonists)
Recovered from prior chemotherapy
At least 2 weeks since prior radiotherapy and recovered
At least 4 weeks since prior investigational drugs
No prior radiotherapy to the whole pelvic field
No unresolved sequelae resulting from any surgical procedures
No concurrent colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) during topotecan infusion
No concurrent participation in another investigational trial
No other concurrent investigational agents
No other concurrent anticancer therapy
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| Name | Affiliation | Role |
|---|---|---|
| Amy Tiersten | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Cancer Institute | New York | New York | 10016 | United States | ||
| Montefiore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24172094 | Result | Stein SM, Tiersten A, Hochster HS, Blank SV, Pothuri B, Curtin J, Shapira I, Levinson B, Ivy P, Joseph B, Guddati AK, Muggia F. A phase 2 study of oxaliplatin combined with continuous infusion topotecan for patients with previously treated ovarian cancer. Int J Gynecol Cancer. 2013 Nov;23(9):1577-82. doi: 10.1097/IGC.0b013e3182a809e0. |
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1 patient never received treatment
A total of 39 patients were enrolled from 3 institutions between January 2006 and October 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Stratum I (Oxaliplatin Plus Topotecan) | Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days. oxaliplatin: Given IV topotecan: Given IV |
| FG001 | Treatment Stratum II (Oxaliplatin Plus Topotecan) | Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days. oxaliplatin: Given IV topotecan: Given IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Stratum I: (Oxaliplatin Plus Topotecan) | Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days. oxaliplatin: Given IV topotecan: 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 |
| 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 | Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) | Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR. | 30 patients were analyzed. Eight patients discontinued treatment before 2 cycles. | Posted | Number | participants | Every two cycles for up to 24 weeks. |
|
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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 | Treatment Stratum I (Oxaliplatin Plus Topotecan) | Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days. oxaliplatin: Given IV topotecan: Given IV |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Investigations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Escobar-Peralta | Montefiore Medical Center | 718-379-6866 | lescobar@montefiore.org |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D019772 | Topotecan |
| C044965 | trioctyl phosphine oxide |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
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| topotecan | Drug | Given IV |
|
|
| The Bronx |
| New York |
| 10467-2490 |
| United States |
| BG001 | Treatment Stratum II (Oxaliplatin Plus Topotecan) | Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days. oxaliplatin: Given IV topotecan: Given IV |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Treatment Stratum II (Oxaliplatin Plus Topotecan) | Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days. oxaliplatin: Given IV topotecan: Given IV |
|
|
| Secondary | Time to Disease Progression by RECIST and/or CA 125 | Time to disease progression by RECIST and/or CA 125 | Posted | Median | 95% Confidence Interval | months | Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks |
|
|
|
| 14 |
| 19 |
| 18 |
| 19 |
| EG001 | Treatment Stratum II (Oxaliplatin Plus Topotecan) | Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days. oxaliplatin: Given IV topotecan: Given IV | 12 | 19 | 18 | 19 |
| Anemia | Blood and lymphatic system disorders |
|
| RBC transfusion | Blood and lymphatic system disorders |
|
| Thrombocytopenia | Investigations |
|
| Platelet transfusion | Investigations |
|
| Diarrhea | Gastrointestinal disorders |
|
| Fatigue | General disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Alanine aminotransferase | Investigations |
|
| Aspartate aminotransferase | Investigations |
|
| Peripheral sensory neuropathy | Nervous system disorders |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Weight loss | Investigations |
|
| Alopecia | Skin and subcutaneous tissue disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Headache | Nervous system disorders |
|
| Mucositis oral | Gastrointestinal disorders |
|
| Abdominal pain | Gastrointestinal disorders |
|
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| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D006571 |
| Heterocyclic Compounds |