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Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer Clinical research trials and Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer. Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer clinical trial. Participants frequently get the best healthcare available for their Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer  Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
For Condition: stage 4A cervical cancer,recurrent cervical cancer,stage 4B cervical cancer,cervical squamous cell carcinoma,stage 3 cervical cancer
Status: Suspended
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: 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 capecitabine in treating patients who have advanced, persistent, or recurrent cervical cancer.
Details: OBJECTIVES: - Determine the activity of capecitabine in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix. - Determine the toxicity profile of this drug in this patient population. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed advanced, persistent, or recurrent squamous cell carcinoma of the cervix - Documented disease progression after local therapy and considered incurable - At least 1 target lesion measurable in at least 1 dimension - At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan - Target lesion cannot be in a previously irradiated field PATIENT CHARACTERISTICS: Age: - Any age Performance status: - GOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGOT no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal: - Creatinine clearance at least 50 mL/min Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No active infection requiring antibiotics - No other invasive malignancy within the past 5 years except nonmelanoma skin cancer - No neuropathy (sensory and motor) greater than grade I PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior biologic therapy or immunotherapy for the malignant tumor - No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: - At least 3 weeks since prior chemotherapy for the malignant tumor and recovered - No prior cytotoxic therapy (except when used as a radiosensitizer) - No prior chemotherapy for other malignancy Endocrine therapy: - At least 1 week since prior hormonal therapy for the malignant tumor - Concurrent hormone replacement therapy allowed Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy for the malignant tumor and recovered - No prior radiotherapy for other malignancy Surgery: - Recovered from prior surgery Other: - At least 3 weeks since any other prior therapy for the malignant tumor - No prior anticancer therapy that contraindicates study therapy - No concurrent amifostine or other protective reagents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AgustinGarcia, Study Chair, University of Southern California
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1065
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Additional Information:
Study ID Numbers: CDR0000068633; GOG-0076CC
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016926
Other Recurrent Cervical Cancer Studies:
1. Bryostatin-1 Plus Cisplatin in Treating Patients With Recurrent or Advanced Cancer of the Cervix
2. Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix
3. Oxaliplatin and Paclitaxel in Treating Patients With Locally Recurrent or Metastatic Cervical Cancer
4. Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
5. EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer
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Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
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