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| Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00039442 |
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 capecitabine in treating patients who have persistent or recurrent cervical cancer.
| Condition | Intervention | Phase |
|
Cervical Cancer |
Drug: capecitabine |
Phase II |
| MedlinePlus related topics: | Cancer Cervical Cancer |
| Drug Information available for: | Capecitabine |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Evaluation Of Capecitabine (NSC #712807) In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix |
| Study Start Date: | June 2002 |
OBJECTIVES:
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 15-37 patients will be accrued for this study within approximately 5-12 months.
Eligibility
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary non-squamous cell carcinoma (non-SCC) of the cervix
Eligible subtypes include:
At least 1 unidimensionally measurable target lesion outside prior irradiation field
Received 1 prior systemic chemotherapy regimen for advanced, metastatic, or recurrent non-SCC of the cervix
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations![]() |
Show 48 Study Locations |
| Gynecologic Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Katherine Y. Look, MD | Indiana University Melvin and Bren Simon Cancer Center |
| Investigator: | Agustin Garcia, MD | Cedars-Sinai Medical Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000069384, GOG-0128G |
| First Received: | June 6, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00039442 |
| Health Authority: | United States: Federal Government |
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