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Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00262821
Recruitment Status : Terminated (Study drug no longer available resulting in lack of study drug for participants.)
First Posted : December 7, 2005
Results First Posted : July 2, 2017
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
NCIC Clinical Trials Group
Gynecologic Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : February 2006
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arms and Interventions
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Arm Intervention/treatment
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:
  • CACP
  • CDDP
  • CPDD
  • DDP
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:
  • CACP
  • CDDP
  • CPDD
  • DDP

Drug: tirapazamine
Given IV
Other Names:
  • SR 4233
  • Tirazone
  • WIN 59075


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262821


Locations
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Sponsors and Collaborators
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Gynecologic Oncology Group
Investigators
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Principal Investigator: Paul DiSilvestro Gynecologic Oncology Group
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262821    
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 )
First Posted: December 7, 2005    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: July 23, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Carcinoma
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
 Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Neoplasms, Complex and Mixed
Tirapazamine
Antineoplastic Agents