Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

NYU Langone Health

Status and phase: Completed; Phase 1

Conditions: Fallopian Tube Cancer; Peritoneal Cavity Cancer; Ovarian Cancer

Treatments: Drug: oxaliplatin; Drug: topotecan hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006391

U01CA070075 (U.S. NIH Grant/Contract)

CDR0000068275

NCI-690

NYU-0016

P30CA016087 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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