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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118300 |
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with radiation therapy in treating patients with locally advanced cervical cancer or other pelvic cancer.
Condition | Intervention | Phase |
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Cervical Cancer Endometrial Cancer Ovarian Cancer Vaginal Cancer |
Drug: capecitabine Radiation: brachytherapy Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Capecitabine (Xeloda) and Radiation Therapy in Patients With Locally Advanced Cervical and Pelvic Malignancies |
Estimated Enrollment: | 24 |
Study Start Date: | April 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of capecitabine.
Patients undergo external beam radiotherapy to the whole pelvis once daily 5 days a week in weeks 1-5 and receive 1 or 2 applications of low-dose rate intracavitary brachytherapy in weeks 7-8 OR 5 applications of high-dose rate (HDR)* intracavitary brachytherapy once weekly in weeks 4-8. Patients also receive oral capecitabine twice daily 7 days a week in weeks 1-5 and 7-8. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
NOTE: *No external beam radiotherapy is administered on the day of HDR brachytherapy. If the majority of external beam radiotherapy has been administered, HDR brachytherapy may be administered in 2 applications per week (separated by at least 72 hours) in order to complete all treatment by week 8.
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the MTD.
After completion of study treatment, patients are followed at 1 month, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: Approximately 4-24 patients will be accrued for this study within 2-12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cervical cancer or other pelvic malignancy, including vaginal, endometrial, or ovarian cancer
Locally advanced disease, defined as the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
No other active invasive malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | Steven E. Waggoner, MD | Case Comprehensive Cancer Center |
Principal Investigator: | Charles Kunos, MD, PhD | Ireland Cancer Center |
Study ID Numbers: | CDR0000433134, CASE-9804, CWRU-010514 |
Study First Received: | July 8, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00118300 History of Changes |
Health Authority: | United States: Federal Government |
stage III cervical cancer stage IVA cervical cancer recurrent cervical cancer stage III endometrial carcinoma recurrent endometrial carcinoma stage III ovarian epithelial cancer recurrent ovarian epithelial cancer stage III ovarian germ cell tumor recurrent ovarian germ cell tumor stage III vaginal cancer |
stage IVA vaginal cancer recurrent vaginal cancer ovarian sarcoma ovarian stromal cancer stage IV endometrial carcinoma stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer stage II vaginal cancer stage I vaginal cancer |
Antimetabolites Gonadal Disorders Vaginal Cancer Urogenital Neoplasms Vaginal Diseases Endometrial Cancer Ovarian Diseases Genital Diseases, Female Endometrial Neoplasms Soft Tissue Sarcomas Uterine Neoplasms Ovarian Cancer Endocrine Gland Neoplasms |
Vaginal Neoplasms Capecitabine Ovarian Neoplasms Genital Neoplasms, Female Endocrine System Diseases Uterine Diseases Ovarian Epithelial Cancer Recurrence Carcinoma Malignant Mesenchymal Tumor Sarcoma Endocrinopathy |
Antimetabolites Vaginal Neoplasms Capecitabine Antimetabolites, Antineoplastic Ovarian Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Uterine Diseases Endocrine System Diseases Vaginal Diseases |
Urogenital Neoplasms Ovarian Diseases Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Endometrial Neoplasms Neoplasms Neoplasms by Site Therapeutic Uses Uterine Neoplasms Endocrine Gland Neoplasms |