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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Agustin Garcia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066478 (5O-98-1)

NCT ID:

NCT00003449

Start Date:

May 1998

Completion Date:

February 2004

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms

Name

Location

USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804