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Sponsors and Collaborators: |
University of Medicine and Dentistry New Jersey National Cancer Institute (NCI) Gynecologic Oncology Group |
Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00704873 |
The purpose of this study is to determine if combining a drug called Tirapazamine (TPZ) with cisplatin during radiation therapy increases progression-free survival (PSF) compared with cisplatin alone and radiation therapy for the treatment of cancer of the cervix. Progression-free survival is one type of measurement that can be used in a clinical study or trial to help determine whether a new treatment is effective. It refers to the probability that a patient will remain alive, without the disease getting worse.
The study will also determine if the addition of Tirapazamine to cisplatin and radiation therapy improves progression-free survival and the type of side-effects that occur with the addition of Tirapazamine to cisplatin in patients with cancer of the cervix.
Condition | Intervention | Phase |
Cervical Cancer |
Drug: cisplatin Drug: tirapazamine |
Phase III |
MedlinePlus related topics: | Cancer Cervical Cancer |
ChemIDplus related topics: | Cisplatin Tirapazamine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine and Radiation in Stage IB2, IIA, IIIB and IVA Cervical Carcinoma Limited to the Pelvis |
Estimated Enrollment: | 750 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).
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Drug: cisplatin
given intravenously for Arm 1:Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). For Arm II: Patients receive cisplatin IV over 1 hour on days 1, 15, and 29 |
2: Experimental
Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26, and 29 and cisplatin IV over 1 hour on days 1, 15, and 29.
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Drug: cisplatin
given intravenously for Arm 1:Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). For Arm II: Patients receive cisplatin IV over 1 hour on days 1, 15, and 29
Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26, and 29
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix
PATIENT CHARACTERISTICS:
PERFORMANCE STATUS
PRIOR CONCURRENT THERAPY:
SURGERY
Contact: Bernadetter Cracchiolo, MD, MPH | 9739725055 | cracchbm@umdnj.edu |
Contact: Yasmeen S Barber, BA | 9739727789 | barberys@umdnj.edu |
United States, New Jersey | |||||
Univeristy of Medicine and Dentistry of New Jersey | Recruiting | ||||
Newark, New Jersey, United States, 07101-1709 | |||||
Contact: Yasmeen S. Barber, BA 973-972-7789 barberys@umdnj.edu | |||||
Sub-Investigator: Margarette Bryan | |||||
Principal Investigator: Bernadette Cracchiolo, MD, MPH | |||||
Sub-Investigator: Dolly Razdan, MD | |||||
Sub-Investigator: Debra Heller, MD |
University of Medicine and Dentistry New Jersey |
National Cancer Institute (NCI) |
Gynecologic Oncology Group |
Study Chair: | PAUL A. DiSILVESTRO, M.D. | Women and Infants' Hospital |
Responsible Party: | Women and Infants Hospital anf Univ of California-Irvine respectively ( PAUL A. DiSILVESTRO, M.D. and BRADLEY MONK, M.D., Study Co-Chairs ) |
Study ID Numbers: | 0120050332 |
First Received: | June 23, 2008 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00704873 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; United States: Gynecologic Oncology Group; United States: National Cancer Institute |
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