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Study Summary
No. GOG 0219:.......Cervix......Robert Coleman......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:		GOG 0219
Study Title:A Phase III, Randomized Trial of Weekly Cisplatin and Radiation versus Cisplatin and Tirapazamine and Radiation in Stage IB2, IIA, IIB, IIIB and IVA Cervical Carcinoma Limited to the Pelvis
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Physician New Patient Referral
Name:Robert ColemanPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3357
Contact us about clinical trials
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General Information
Disease Group:CervixSupported By:N/A
Phase of Study:Phase IIIReturn
Visit:		BOTH REGIMENS: Daily for 35 days, then 2 to 5 times between days 36 and 56.
Follow up examinations and x-rays at regular intervals per the
patient/participant evaluation table above.
Treatment
Agents:		Cisplatin
Radiation
Tirapazamine		Home Care:none
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		If surgically staged, one 3-5 day stay
Description/
Intervention:		The goal of this clinical research study is to determine if combining
tirapazamine (TPZ) with cisplatin during radiation therapy is more effective
than cisplatin and radiation therapy alone.
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Study Objectives / Outcomes
Patients with clinical stages IB2, IIA, IIB, IIB & IVA cervical carcinoma limited to the pelvis will be randomized to receive primary radiotherapy w/ cisplaton or cisplatin in combo w/ tirapazamine (TPZ) chemo. TPZ is bioreductively activated, hypoxia-selective antitumor agent of the benzotriazine series. Tirapazamine increases cisplatin cytotoxicity (both in vitro & in vivo) & in studies in both head & neck & cervical cancer has demonstrated efficacy.

Clinical Objectives
Primary Objective
· Determine if combining TPZ w/ cisplatin during radiation therapy increases progression–free survival (PFS) when compared w/ weekly cisplatin & radiation therapy in this patient population.

Secondary Objectives:
· Determine if addition of TPZ to cisplatin & radiation therapy in this patient population improves overall survival.
· Determine relative toxicities of addition of TPZ to cisplatin in this patient population.
    Translational Research Objectives
    Overall objectives of translational research component of this protocol are to test hypothesis that TPZ will be more effective in tumors that express high compared w/ low levels of hypoxia marker carbonic anhydrase (CA-IX) & to assess clinical relevance of specific biological markers of hypoxia & angiogenesis in fixed primary tumor tissue & serial serum specimens from patients w/ clinical stages IB2, IIA, IIB, IIIB, & IV A cervical carcinoma limited to pelvis receiving concurrent chemoradiation w/ cisplatin -vs- cisplatin + TPZ.

    Main Objective
    · Determine whether evidence of interaction exists between study treatment & tumor expression of CA-IX in relation to RFS, overall survival or metastasis.

    Exploratory Objectives
    · Evaluate whether expression of CA-IX, hypoxia inducible factor-1á (HIF-1á), CD-31, thrombospondin-1 (TSP-1), CD-105 (also called endoglin) or vascular endothelial growth factor (VEGF) in primary tumor tissue predicts RFS, overall survival or metastasis.
    · Examine whether serum concentrations of angiogenic markers including angiogenin or VEGF predict RFS, overall survival or metastasis.
    · Study association among biological markers of hypoxia & angiogenesis.
    · Compare predictability of various combinations of biological markers of hypoxia & angiogenesis in relation to RFS, overall survival or metastasis
    · Assess whether levels of individual biological markers of hypoxia or angiogenesis are associated w/ clinicopathological characteristics including tumor size, histologic subtype, FIGO stage, depth of invasion, pelvic node status, site of recurrence, hemoglobin (Hgb) level as well as patient, age, race & performance status.
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    Study Status Information
    Study Activation / Registration Date:04/18/2006
    IRB Review and Approval Date:03/15/2006
    Study Type:Therapeutic
    Recruitment Status:Closed
    Projected Accrual:750
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    Inclusion Criteria:1) Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, stages IB2, IIA, IIB, IIIB, and IVA. (Stage IIA tumors must be greater than 4 cm.)

    2) Patients with negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT, PET CT, MRI or lymphadenectomy.

    3) Patients with adeuate bone marrow function: ANC greater than or equal to 1,500/mcl; platelets greater than or equal to 100,000/mcl.

    4) Patients with adequate renal function: creatinine </= ULN (CTC Grade 0) or calculated creatinine clearance (Jeliffe Formula) >/= 60ml/min.

    5) Patients with adequate hepatic function: bilirubin less than or equal to 1.5 x ULN and SGOT and alkaline phosphatase less than or equal to 3 x ULN.

    6) Patients who have met the pre-entry requirements (see Patient/Participant Evaluation -- Pre-treatment and Interim Testing table, Prior to Entry column).

    7) Patients who have signed an approved informed consent and authorization permitting release of personal health information.

    8) Patients with GOG Performance Status of 0, 1, 2, or 3.

    9) Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.

    10) Patients who are suitable for treatment with radical intent using concurrent chemotherapy and pelvic radiation.
    Exclusion Criteria:1) Patients who cannot be or have not been adequately clinically staged.

    2) Patients whose diagnosis cannot be histologically confirmed.

    3) Patients with lower one-third vaginal involvement regardless of stage (all stage IIIA, IIIB, and IVA with lower one-third involvement).

    4) Patients who have undergone hysterectomy or will have a hysterectomy as part of their initial cervix cancer therapy.

    5) Patients with septicemia or severe infection.

    6) Patients with circumstances that will not permit completion of the study or required follow-up.

    7) Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other canc er present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.

    8) Patients with carcinoma of the cervical stump.

    9) Patients with uncontrolled hypertension.

    10) Patients who are pregnant or lactating.

    11) Patients with a history of cardiovascular disease manifested as: (1) history of myocardial infarction, (2) unstable angina, (3) currently taking angina medication, (4) history of coronary artery bypass surgery, (5) New York Heart Association class 3 or 4 heart failure.

    12) Patients with a known hypersensitivity to Cisplatin or other platinum-containing compounds who are not eligible for a desensitization program.
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    Links
    Registration Number: NCT00262821
    Study Information on Clinical Trials Registry (clinicaltrials.gov)
    Other Links:
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    Results

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