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
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Howard S. Hochster, MD
Investigator Role:
Study Chair
Investigator Affiliation:
New York University School of Medicine
Authority:
United States: Federal Government
Study ID:
CDR0000068275
NCT ID:
NCT00006391
Start Date:
August 2000
Completion Date:
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Peritoneal Cavity Cancer
- recurrent ovarian epithelial cancer
- fallopian tube cancer
- peritoneal cavity cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
