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



Status:Recruiting
Conditions:Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:11/30/-0001
Start Date:February 2006

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A Phase III, Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine (IND #46525) and Radiation in Stage IB2, IIA, IIIB and IVA Cervical Carcinoma Limited to the Pelvis


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.


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.

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
We found this trial at
273
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450 Lakeville Rd
Lake Success, New York 11040
(516) 734-8900
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Fort Myers, Florida 33901
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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185 S Orange Ave
Newark, New Jersey 07103
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UMDNJ-New Jersey Medical School NJMS is committed to educating humanistic, culturally competent physicians who will...
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1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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1200 Old York Road
Abington, Pennsylvania 19001
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98-1079 Moanalua Rd
Aiea, Hawaii 96701
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1 Akron General Ave
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489 State St
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265 Fremont St
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2900 12th Ave N Ste 160W
Billings, Montana 59101
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500 N 8th St
Bismarck, North Dakota 58501
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900 E Broadway Ave
Bismarck, North Dakota 58501
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Bismarck, North Dakota 58501
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2200 E Washington St,
Bloomington, Illinois 61701
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1 Cooper Plaza
Camden, New Jersey 08103
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Canton, Ohio 44710
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20126 Stanton Ave
Castro Valley, California 94546
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
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Charlottesville, Virginia 22903
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Chattanooga, Tennessee 37403
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Chattanooga, Tennessee 37403
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1653 W. Congress Parkway
Chicago, Illinois 60612
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1200 West Harrison Stree
Chicago, Illinois 60607
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5841 S Maryland Ave
Chicago, Illinois 60637
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2600 Clifton Ave
Cincinnati, Ohio 45267
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Cincinnati, Ohio 45220
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2500 Metrohealth Dr
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2049 E 100th St
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18101 Lorain Avenue
Cleveland, Ohio 44111
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Colorado Springs, Colorado 80909
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1 Hospital Dr
Columbia, Missouri 65212
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Columbus, Ohio 43222
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3535 Olentangy River Rd
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
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Durham, North Carolina 27710
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Escanaba, Michigan 49829
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