Overview

Combination Chemotherapy in Treating Patients With Platinum-Resistant Recurrent Ovarian Cancer

Status:
Completed
Trial end date:
2004-02-01
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 II trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Southern California
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Dexamethasone
Gemcitabine
Paclitaxel
Criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent ovarian epithelial cancer

- Platinum resistant disease defined as:

- Progression during the most recent platinum-based chemotherapy OR

- Relapse less than 6 months after platinum-based chemotherapy

- Measurable or evaluable disease

- Elevated CA-125 only allowed

- Positive cytology only not eligible

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- SWOG 0-2

Hematopoietic:

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin less than 2 times upper limit of normal (ULN)

- AST less than 3 times ULN

Renal:

- Creatinine no greater than 2 mg/dL

Neurologic:

- No peripheral neuropathy greater than grade 2

Other:

- No other serious medical illness or psychiatric conditions.

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent hematopoietic growth factors

Chemotherapy:

- See Disease Characteristics

- No prior gemcitabine

- No prior paclitaxel administered weekly

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- Recovered from acute toxic effects secondary to prior therapy