Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin with topotecan in treating patients who have previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: oxaliplatin Drug: topotecan hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Dose-Finding Study of Oxaliplatin (NSC #266046) Combined With Continuous Infusion Topotecan Hydrochloride as Chemotherapy for Patients With Previously Treated Ovarian Cancer |
| Study Start Date: | August 2000 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxic effects of oxaliplatin and topotecan in patients with previously treated ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.
- Determine the qualitative and quantitative toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the antitumor activity of this treatment regimen in these patients.
- Determine the correlation between the pharmacokinetic and safety data of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with measurable disease who achieve a response may receive additional therapy at the discretion of the principal investigator.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed through day 30.
PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer
- Prior chemotherapy required
- Measurable or evaluable disease
- No symptomatic, untreated brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- At least 4 months
Hematopoietic:
- WBC greater than 3,000/mm^3
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
- SGOT no greater than 2.5 times ULN (5 times ULN if liver metastases)
Renal:
- Creatinine no greater than 1.5 times ULN OR
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No uncontrolled symptomatic congestive heart failure
- No unstable angina pectoris
- No uncontrolled cardiac arrhythmia
Other:
- No other active cancer
- No prior allergy to platinum compounds
- No prior allergic reactions to appropriate antiemetics (e.g., serotonin or antagonists) administered concurrently with study
- No other uncontrolled concurrent illness (e.g., infection)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Chemotherapy
- No concurrent colony stimulating factors during topotecan administration
Chemotherapy:
- See Disease Characteristics
- No prior high-dose chemotherapy requiring bone marrow or peripheral blood stem cell transplantation
- At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to whole pelvic field
- At least 2 weeks since prior radiotherapy and recovered
Surgery:
- No unresolved sequelae resulting from prior surgery
Other:
- At least 4 weeks since other prior investigational drug
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Contacts and Locations| United States, New York | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| Study Chair: | Howard S. Hochster, MD | New York University School of Medicine |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00006391 History of Changes |
| Other Study ID Numbers: | CDR0000068275, U01CA070075, P30CA016087, NYU-0016, NCI-690 |
| Study First Received: | October 4, 2000 |
| Last Updated: | April 4, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by New York University School of Medicine:
|
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Oxaliplatin Topotecan Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013