NCT00006482TerminatedPhase 2
A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Gynecologic Oncology Group
- Locations
- 34
Study Overview
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 combining gemcitabine and cisplatin in treating patients who have refractory or recurrent cancer of the cervix.
Detailed Description
OBJECTIVES:
- Determine the antitumor activity of gemcitabine and cisplatin in patients with refractory or recurrent squamous cell carcinoma of the cervix.
- Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV and gemcitabine IV over 1 hour on days 1 and 8. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapy and is considered incurable
- •Must have had 1 prior chemotherapy regimen for cervical cancer
- •No more than 1 prior chemotherapy regimen (single or combination drug therapy), unless used as a radiosensitizer
- •No prior chemotherapy for recurrent or persistent disease including retreatment with initial chemotherapy
- •Bidimensionally measurable disease
- •Ineligible for higher priority GOG protocol
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count at least lower limit of normal
- •Absolute neutrophil count at least 1,500/mm^3
- •Bilirubin no greater than 1.5 times normal
- •SGOT and alkaline phosphatase no greater than 3 times normal
- •Creatinine no greater than 2.0 mg/dL
- •Not pregnant
- •Fertile patients must use effective contraception
- •No significant infection
- •No other malignancies within past 5 years except nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior biologic therapy for cervical cancer
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy for cervical cancer and recovered
- •No prior gemcitabine
- •Endocrine therapy:
- •At least 3 weeks since prior endocrine therapy for cervical cancer
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy for cervical cancer and recovered
- •No prior radiotherapy to more than 25% of marrow-bearing areas
- •At least 3 weeks since prior surgery for cervical cancer and recovered
- •No concurrent amifostine or other protective reagents
- •No prior anticancer therapy that contraindicates study
Exclusion Criteria
- Not provided
Investigators
Study Sites (34)
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