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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003449
• Other study ID #: CDR0000066478 (5O-98-1)
• Secondary ID: LAC-USC-5O981NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: May 20, 2014
• Start date: May 1998
• Est. completion date: February 2004

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2004
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• dexamethasone

• gemcitabine hydrochloride

• paclitaxel

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,