Gemcitabine in Treating Patients With Persistent 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.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have persistent or recurrent cancer of the cervix.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: gemcitabine hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Evaluation of Gemcitabine in Persistent or Recurrent Non-Squamous Cell Carcinoma of the Cervix |
| Study Start Date: | September 2000 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks 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: Approximately 15-37 patients will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable
Eligible subtypes:
- Adenocarcinoma
- Adenosquamous carcinoma
- Undifferentiated carcinoma
- Must have documented disease progression
- Histologic confirmation of original primary tumor required
- Bidimensionally measurable disease
- Ineligible for higher priority GOG protocol
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 100,000/mm^3
- Granulocyte 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 1.5 mg/dL
Other:
- No significant infection
- Not pregnant
- Fertile patients must use effective contraception
- No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent filgrastim (G-CSF)
Chemotherapy:
- No prior gemcitabine
- At least 3 weeks since other prior chemotherapy for cervical cancer and recovered
- No more than 1 prior chemotherapy regimen (single or combination cytotoxic therapy)
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 3 weeks since prior radiotherapy for cervical cancer and recovered
Surgery:
- At least 3 weeks since prior surgery for cervical cancer and recovered
Other:
- No prior cancer treatment that would preclude study
Contacts and Locations
Show 39 Study Locations| Study Chair: | Russell J. Schilder, MD | Fox Chase Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00006224 History of Changes |
| Other Study ID Numbers: | CDR0000068144, GOG-0128F |
| Study First Received: | September 11, 2000 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Gynecologic Oncology Group:
|
recurrent cervical cancer cervical adenocarcinoma cervical adenosquamous cell carcinoma |
Additional relevant MeSH terms:
|
Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Gemcitabine Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 19, 2013