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
|Recurrent Cervical Cancer Recurrent Ovarian Epithelial Cancer Recurrent Vaginal Cancer Recurrent Vulvar Cancer Stage III Vaginal Cancer Stage IIIA Cervical Cancer Stage IIIA Ovarian Epithelial Cancer Stage IIIA Vulvar Cancer Stage IIIB Cervical Cancer Stage IIIB Ovarian Epithelial Cancer Stage IIIB Vulvar Cancer Stage IIIC Ovarian Epithelial Cancer Stage IIIC Vulvar Cancer Stage IV Ovarian Epithelial Cancer Stage IVA Cervical Cancer Stage IVA Vaginal Cancer Stage IVB Cervical Cancer Stage IVB Vaginal Cancer||Drug: triapine Other: laboratory biomarker analysis Radiation: external beam radiation therapy Radiation: brachytherapy Drug: cisplatin Other: pharmacological study||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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.|
- Toxicity of radiotherapy and Triapine® combination therapy as documented by dose-limiting toxicities (DLTs) using Common Terminology Criteria for Adverse Events (CTCAE) criteria, version 3.0 [ Time Frame: Up to 12 weeks ]
- MTD of Triapine® when given in combination with pelvic radiotherapy with or without weekly intravenous cisplatin chemotherapy [ Time Frame: 12 weeks ]
- RR R2 enzyme quantity [ Time Frame: Baseline ]Paired T-tests will be used to compare RR R2 enzyme quantity and activity before and after treatment. %MHgb levels will be tracked over time with corresponding pharmacokinetic and biopsy analyses and tested for time course correlations with plasma Triapine® concentrations.
- RR R2 enzyme quantity [ Time Frame: Day 10 ]Paired T-tests will be used to compare RR R2 enzyme quantity and activity before and after treatment. %MHgb levels will be tracked over time with corresponding pharmacokinetic and biopsy analyses and tested for time course correlations with plasma Triapine® concentrations.
|Study Start Date:||March 2006|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Experimental: Treatment (triapine)
Group 1: Patients undergo external-beam pelvic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive 3-AP IV over 2 hours on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33 and cisplatin IV over 1½ hours on day 2, 9, 16, 23, and 30.
Group 2: Patients undergo external-beam pelvic radiotherapy and receive 3-AP as in group 1.
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.
Other Names:Other: laboratory biomarker analysis
Correlative studiesRadiation: external beam radiation therapy
Undergo external beam radiation therapy
Other Name: EBRTRadiation: brachytherapy
Undergo intracavitary or interstitial brachytherapy
Other Names:Drug: cisplatin
Other Names:Other: pharmacological study
Other Name: pharmacological studies
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00335998
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Charles Kunos||Case Western Reserve University|