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Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
This study has been terminated.
(Study drug no longer available resulting in lack of study drug for participants.)
Sponsor:
National Cancer Institute (NCI)
Collaborator:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00262821
First received: December 6, 2005
Last updated: May 30, 2017
Last verified: May 2017
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Purpose
This randomized phase III trial is studying cisplatin, radiation therapy, and tirapazamine to see how well they work compared to cisplatin and radiation therapy in treating patients with cervical cancer. Drugs used in chemotherapy, such as cisplatin and tirapazamine, 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 to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin and tirapazamine may make tumor cells more sensitive to radiation therapy. It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without tirapazamine in treating cervical cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Cervical Adenocarcinoma Cervical Adenosquamous Cell Carcinoma Cervical Squamous Cell Carcinoma Stage IB Cervical Cancer Stage IIA Cervical Cancer Stage IIB Cervical Cancer Stage III Cervical Cancer Stage IVA Cervical Cancer | Drug: cisplatin Drug: tirapazamine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Progression-free Survival - Percentage of Patients Alive and Progression Free [ Time Frame: From study entry until first disease progression, death or date of last contact, up to 6 years ]Patients' progression status based on clinical, radiological or pathological (histological) evidence of disease after study therapy. Progression includes any death without evidence of disease progression. Progression-free Survival (PFS) is defined as time in month from study enrollment to disease progression, death or date of last contact.
Secondary Outcome Measures:
- Overall Survival [ Time Frame: From study entry to death or last contact, up to 6 years ]The observed length of life from entry into the study to death or date of last contact.
- Adverse Events (Grade 3 or Higher) During Treatment Period [ Time Frame: All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported ]Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v3.0.
| Enrollment: | 402 |
| Study Start Date: | February 2006 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I (cisplatin)
Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).
|
Drug: cisplatin
Given IV
Other Names:
|
|
Experimental: Arm II (cisplatin, tirapazamine)
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.
|
Drug: cisplatin
Given IV
Other Names:
Drug: tirapazamine
Given IV
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
-
Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix
-
Stage IB2, IIA, IIB, IIIB, or IVA disease
- Stage IIA tumors must be > 4 cm
- Primary, untreated disease
-
- Negative, non-suspicious para-aortic nodes by lymphangiogram, CT scan, MRI, or lymphadenectomy
- Must have been adequately clinically staged
- Suitable for treatment with radical intent using concurrent chemotherapy and pelvic radiotherapy
- No disease involvement of the lower third of the vagina regardless of stage (all stage IIIA, IIIB and IVA with lower one-third involvement)
- No carcinoma of the cervical stump
- Performance status - GOG 0-3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 3 times ULN
- Alkaline phosphatase ≤ 3 times ULN
- Creatinine ≤ ULN or calculated creatinine clearance ≥ 60mL/min
- No New York Heart Association class III-IV heart failure
- No history of myocardial infarction
- No unstable angina
- No uncontrolled hypertension
- No pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No septicemia or severe infection
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No prior hysterectomy or planned hysterectomy as part of initial cervix cancer therapy
- No prior coronary artery bypass surgery
- No prior cancer therapy that would preclude study treatment
- No concurrent angina medication
- No concurrent intensity-modulated radiotherapy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262821
Show 282 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262821
Show 282 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Investigators
| Principal Investigator: | Paul DiSilvestro | Gynecologic Oncology Group |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00262821 History of Changes |
| Obsolete Identifiers: | NCT00704873 |
| Other Study ID Numbers: |
NCI-2009-00591 NCI-2009-00591 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CAN-NCIC-GOG-0219 CDR0000455555 GOG-0219 ( Other Identifier: Gynecologic Oncology Group ) GOG-0219 ( Other Identifier: CTEP ) U10CA027469 ( U.S. NIH Grant/Contract ) |
| Study First Received: | December 6, 2005 |
| Results First Received: | October 9, 2015 |
| Last Updated: | May 30, 2017 |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Adenocarcinoma Uterine Cervical Neoplasms Carcinoma, Adenosquamous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Uterine Neoplasms |
Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Tirapazamine Cisplatin Antineoplastic Agents |
ClinicalTrials.gov processed this record on July 17, 2017