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Cisplatin and Radiation Thera...

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

Last Updated: 2019-07-23

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVE:

I. Compare the progression-free survival of patients with stage IB, IIA, IIB, IIIB, or IVA carcinoma of the cervix treated with cisplatin and radiotherapy with vs without tirapazamine.

SECONDARY OBJECTIVES:

I. Compare overall survival of patients treated with these regimens. II. Compare the toxicity of these regimens in these patients.

TERTIARY OBJECTIVES:

I. Correlate study treatment with tumor expression of carbonic anhydrase IX (CA-IX) and recurrence-free survival, overall survival, or metastasis in patients treated with these regimens.

II. Correlate expression of CA-IX, hypoxia inducible factor-1α, CD-31, thrombospondin-1, CD-105, or vascular endothelial growth factor (VEGF) in primary tumor tissue with recurrence-free survival, overall survival, or metastasis in patients treated with these regimens.

III. Correlate pre-treatment and/or post-treatment serum concentrations of angiogenic markers including angiogenin or VEGF with recurrence-free survival, overall survival, or metastasis in patients treated with these regimens.

IV. Correlate various combinations of biological markers of hypoxia and angiogenesis with recurrence-free survival, overall survival, or metastasis in patients treated with these regimens.

V. Correlate levels of individual biological markers of hypoxia or angiogenesis with clinicopathological characteristics including tumor size, histologic subtype, FIGO stage, depth of invasion, pelvic node status, site of recurrence, and hemoglobin level as well as patient, age, race and performance status in patients treated with these regimens.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to FIGO stage of disease (IB2 vs IIA vs IIB vs IIIB vs IVA), brachytherapy method (low-dose rate vs high-dose rate), surgical staging of para-aortic nodes (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin IV over 30-60 minutes once weekly on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). Patients also undergo external beam radiotherapy to the pelvis once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33 (weeks 1-5). Patients then receive either 1 or 2 applications of low-dose rate brachytherapy in weeks 6-8 OR 5 applications of high-dose rate (HDR)\* brachytherapy once weekly in weeks 4-8 and 3-5 days of parametrial boost radiotherapy\*\* beginning after the first brachytherapy implant. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM II: 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. Patients also undergo radiotherapy and brachytherapy as in arm I. Treatment continues in the absence of disease progression or unacceptable toxicity.

NOTE: \*No external beam radiotherapy is administered on the day of HDR brachytherapy. If the majority of external beam radiotherapy has been administered, HDR brachytherapy may be administered in 2 applications per week (separated by at least 72 hours) in order to complete all treatment within 8 weeks.

NOTE: \*\* Patients may receive a parametrial boost at the discretion of the treating radiation oncologist.

After completion of study treatment, patients are followed for at least 5 years.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (cisplatin)

Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).

Group Type ACTIVE_COMPARATOR

cisplatin

Intervention Type DRUG

Given IV

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.

Group Type EXPERIMENTAL

cisplatin

Intervention Type DRUG

Given IV

tirapazamine

Intervention Type DRUG

Given IV

Interventions

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cisplatin

Given IV

Intervention Type DRUG

tirapazamine

Given IV

Intervention Type DRUG

Other Intervention Names

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CACP CDDP CPDD DDP SR 4233 Tirazone WIN 59075

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul DiSilvestro

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Banner Good Samaritan Medical Center

Phoenix, Arizona, United States

Site Status

Western Regional CCOP

Phoenix, Arizona, United States

Site Status

Highlands Oncology Group PA - Fayetteville

Fayetteville, Arkansas, United States

Site Status

Washington Regional Medical Center - Fayetteville

Fayetteville, Arkansas, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

East Bay Radiation Oncology Center

Castro Valley, California, United States

Site Status

City of Hope Medical Center

Duarte, California, United States

Site Status

Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Bay Area Tumor Institute CCOP

Oakland, California, United States

Site Status

University of California Medical Center At Irvine-Orange Campus

Orange, California, United States

Site Status

Pomona Valley Hospital Medical Center

Pomona, California, United States

Site Status

Stanford University Hospitals and Clinics

Stanford, California, United States

Site Status

Olive View-University of California Los Angeles Medical Center

Sylmar, California, United States

Site Status

Colorado Gynecologic Oncology Group

Aurora, Colorado, United States

Site Status

Memorial Hospital Colorado Springs

Colorado Springs, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Beebe Medical Center

Lewes, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Florida Gynecologic Oncology

Fort Myers, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

UF Cancer Center at Orlando Health

Orlando, Florida, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Northside Hospital

Atlanta, Georgia, United States

Site Status

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

Site Status

Georgia Regents University

Augusta, Georgia, United States

Site Status

John B Amos Cancer Center

Columbus, Georgia, United States

Site Status

Dekalb Medical Center

Decatur, Georgia, United States

Site Status

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Site Status

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

Hawaii Minority Based CCOP

Honolulu, Hawaii, United States

Site Status

Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

Straub Clinic and Hospital

Honolulu, Hawaii, United States

Site Status

University of Hawaii

Honolulu, Hawaii, United States

Site Status

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Site Status

Tripler Army Medical Center

Honolulu, Hawaii, United States

Site Status

Maui Memorial Medical Center

Wailuku, Hawaii, United States

Site Status

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Site Status

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status

Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital Association

Canton, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Illinois

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Saint Francis Hospital

Evanston, Illinois, United States

Site Status

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates Limited

Joliet, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center Foundation

Normal, Illinois, United States

Site Status

Advocate Lutheran General Hospital.

Park Ridge, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Valley Radiation Oncology

Peru, Illinois, United States

Site Status

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Carle Clinic-Urbana Main

Urbana, Illinois, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Indiana University Medical Center

Indianapolis, Indiana, United States

Site Status

Gynecologic Oncology of Indiana

Indianapolis, Indiana, United States

Site Status

Community Howard Regional Health

Kokomo, Indiana, United States

Site Status

IU Health La Porte Hospital

La Porte, Indiana, United States

Site Status

Franciscan Saint Anthony Health-Michigan City

Michigan City, Indiana, United States

Site Status

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Site Status

McFarland Clinic PC-William R Bliss Cancer Center

Ames, Iowa, United States

Site Status