Brief Title
Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
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
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 1
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
oxaliplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
August 2000
Primary Completion Date
November 2004
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Howard S. Hochster, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00006391
Organization ID
CDR0000068275
Secondary IDs
U01CA070075
Study Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Howard S. Hochster, MD, Study Chair, NYU Langone Health
Verification Date
April 2011