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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: National Cancer Institute (NCI)
• Treatments: Oxaliplatin; Topotecan

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