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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: | NCT00335998 |
RATIONALE: Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 3-AP may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. 3-AP and cisplatin may make tumor cells more sensitive to radiation therapy. Giving 3-AP and external-beam radiation therapy together with cisplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of 3-AP when given together with external-beam radiation therapy with or without cisplatin in treating patients with gynecologic cancer.
Condition | Intervention | Phase |
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Cervical Cancer Endometrial Cancer Ovarian Cancer Vaginal Cancer Vulvar Cancer |
Drug: cisplatin Drug: triapine Procedure: brachytherapy Procedure: flow cytometry Procedure: immunoenzyme technique Procedure: molecular diagnostic method Procedure: pharmacological study Procedure: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Intravenous Triapine (IND # 68338) in Combination With Pelvic Radiation Therapy With or Without Weekly Intravenous Cisplatin Chemotherapy for Locally Advanced Cervical, Vaginal, or Pelvic Gynecologic Malignancies |
Estimated Enrollment: | 24 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of 3-AP. Patients are assigned to 1 of 2 treatment groups based on eligibility* to receive cisplatin (yes vs no).
NOTE: *Patients who refuse or are not candidates for cisplatin chemotherapy due to prior platinum adverse sensitivity, active neuropathy, or comobid illness, as determined by the treating physician, are eligible to receive 3-AP alone with pelvic radiotherapy.
In both groups, patients undergo intracavitary or interstitial brachytherapy at least once weekly for 3-5 weeks during or after external-beam radiotherapy as per standard of care.
Cohorts of 3-6 patients in group 1 and 1-3 patients in group 2 receive escalating doses of 3-AP 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. At least 6 patients are treated at the MTD.
Patients undergo blood draws on days 1 and 10 before treatment with 3-AP and at 2, 4, 6, and 24 hours after starting treatment to assess methemoglobin levels and 3-AP plasma levels. Patients also undergo punch biopsy on days 1 and 10 to determine R2 protein levels by Western blot analysis, ribonucleotide reductase R2 protein levels by flow cytometry, and cytidine deoxyphosphate reductase assay.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed diagnosis of 1 of the following:
Recurrent or persistent ovarian epithelial or endometrial cancer meeting all of the following criteria:
PATIENT CHARACTERISTICS:
No other uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
Geauga Regional Hospital | |
Chardonr, Ohio, United States, 44024 | |
Lake/University Ireland Cancer Center | |
Mentor, Ohio, United States, 44060 | |
Mercy Cancer Center at Mercy Medical Center | |
Canton, Ohio, United States, 44708 | |
University Suburban Health Center | |
South Euclid, Ohio, United States, 44121 | |
UHHS Chagrin Highlands Medical Center | |
Orange Villager, Ohio, United States, 44122 | |
UHHS Westlake Medical Center | |
Westlaker, Ohio, United States, 44145 | |
Southwest General Health Center | |
Middleburgh Heights, Ohio, United States, 44130 |
Study Chair: | Timothy J. Kinsella, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000471217, CASE-1805, NCI-7336, CASE-110534 |
Study First Received: | June 8, 2006 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00335998 |
Health Authority: | United States: Food and Drug Administration |
recurrent vaginal cancer recurrent vulvar cancer recurrent cervical cancer recurrent endometrial carcinoma recurrent ovarian epithelial cancer stage III vulvar cancer stage IV vulvar cancer stage III vaginal cancer stage IVA vaginal cancer |
stage IVB vaginal cancer stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer stage III endometrial carcinoma stage IV endometrial carcinoma stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
Ovarian cancer Vaginal Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Vaginal cancer Uterine Diseases Endocrine System Diseases Vaginal Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer |
Recurrence Carcinoma Genital Diseases, Female Endometrial Neoplasms Cisplatin Vulvar Neoplasms Uterine Neoplasms Endocrinopathy Endometrial cancer Vulvar Diseases Vulvar cancer Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions Adnexal Diseases |