Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix |
| Study Start Date: | October 2000 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
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.
PROJECTED ACCRUAL: A total of 28-69 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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:
Age:
- Not specified
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least lower limit of normal
- Absolute neutrophil count at least 1,500/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT and alkaline phosphatase no greater than 3 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- 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
Surgery:
- At least 3 weeks since prior surgery for cervical cancer and recovered
Other:
- No concurrent amifostine or other protective reagents
- No prior anticancer therapy that contraindicates study
Contacts and Locations
Show 34 Study Locations| Study Chair: | Cheryl A. Brewer, MD | University of Illinois College of Medicine at Peoria |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00006482 History of Changes |
| Other Study ID Numbers: | CDR0000068313, GOG-0127Q |
| Study First Received: | November 6, 2000 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Gynecologic Oncology Group:
|
recurrent cervical cancer stage IVB cervical cancer stage IVA cervical cancer cervical squamous cell carcinoma |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Uterine Cervical Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Gemcitabine |
Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013