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

University of Southern California

Status and phase: Completed; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: dexamethasone; Drug: gemcitabine hydrochloride; Drug: paclitaxel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003449

NCI-G98-1460

CDR0000066478 (5O-98-1)

LAC-USC-5O981

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 II trial to study the effectiveness of dexamethasone plus paclitaxel and gemcitabine in treating patients with platinum-resistant recurrent ovarian cancer.

Full description

OBJECTIVES:

• Determine the response rate, progression time, and survival of patients with platinum-resistant ovarian cancer treated with weekly paclitaxel and gemcitabine.
• Determine the toxic effects of this regimen in these patients.
• Evaluate the toxic effects and safety profile of premedication with steroids with this regimen in these patients.

OUTLINE: Patients are stratified according to prior treatment with paclitaxel (none or relapse more than 6 months after paclitaxel versus progressive disease or relapse less than 6 months after paclitaxel).

Patients receive dexamethasone IV, then paclitaxel IV followed by gemcitabine IV, for 3 consecutive weeks on days 1, 8, and 15. Treatment is continued every 4 weeks in the absence of disease progression or unacceptable toxicity.

All patients are followed until death.

PROJECTED ACCRUAL: Approximately 18-35 patients will be accrued for this study.

Enrollment: 35 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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