Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Cancer

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of topotecan combined with carboplatin and paclitaxel in treating patients who have stage II, stage III, or stage IV ovarian cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IIB, IIC, III, or IV ovarian epithelial cancer

• Measurable or evaluable lesion or microscopic residual disease after first surgery (phase II patients)

• No brain and/or leptomeningeal metastases by CT scan or MRI unless asymptomatic without corticosteroid therapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Hemoglobin at least 9.0 g/dL

• WBC at least 3,500/mm3

• Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN) unless liver metastases present

• Alkaline phosphatase no greater than 2 times ULN*

• SGOT no greater than 2 times ULN* NOTE: *No greater than 5 times ULN if liver metastases present

Renal:

• Creatinine no greater than 1.5 times ULN

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No symptomatic cardiac disease, including clinical congestive heart failure or arrhythmias requiring treatment

• No myocardial infarction within the past 3 months

Other:

• No other malignancy except basal or squamous cell skin cancer or carcinoma in situ of the cervix

• No uncontrolled infection

• No complete bowel obstruction or other condition that would affect GI absorption or motility

• No concurrent medical condition for which treatment with platinum, taxane, or camptothecin analogues are contraindicated

• No other concurrent medical conditions that would preclude study

• No mental disease

• No history of allergy to platinum or taxanes, including drugs containing cremophor (e.g., cyclosporine or vitamin K)

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No prior camptothecin analogue

• No prior chemotherapy for ovarian cancer

• No other concurrent chemotherapy

Endocrine therapy:

• See Disease Characteristics

• No concurrent hormonal therapy other than estrogen replacement

Radiotherapy:

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 30 days or 5 half-lives since any prior investigational therapy

• No other concurrent investigational therapy

• No concurrent metoclopramide or cisapride