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

Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003449

Enrollment

Registered

2003-09-24

Start date

1998-05-31

Completion date

2004-02-29

Last updated

2014-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer

Brief 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.

Detailed 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.

Interventions

DRUGdexamethasone

DRUGgemcitabine hydrochloride

DRUGpaclitaxel

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026