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Study Summary
No. GOG-0204:.......Cervix......Charles Levenback......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:
GOG-0204
Study Title:A Randomized Phase III Study of Paclitaxel plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin in Stage IVB, Recurrent or Persistent Carcinoma of the Cervix
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Physician New Patient Referral
Name:Charles LevenbackPatients 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:713-745-2563
Contact us about clinical trials
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General Information
Disease Group:CervixSupported By:Gynecologic Oncology Group
Phase of Study:Phase IIIReturn
Visit:
Every 3 weeks for 6 treatment visits; after treatment, follow-up visits every 3 months for two years, then every 6 months for 3 years.
Treatment
Agents:
Collection
Questionaire
Imaging
Cisplatin
Paclitaxel
Navelbine
Home Care:None
Treatment Loc:outpatient
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
Unavailable
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Study Status Information
Study Activation / Registration Date:08/22/2003
IRB Review and Approval Date:07/02/2003
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:40
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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:Patients must have histologiclly proven Stage IVB, recurrent or persistent Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy.

All patients must have measurable disease. See protocol for description of "measurable disease".

Patients must have adequate Hematologic function: ANC equal to or greater than 1500/ul- platelets equal to or greater than 100,000/ul.

Patients must have adequate hepatic function. Bilirubin equal to or less than 1.5 x institutional normal- SGOT, alkaline pphosphatase equal to or less than 3x institutional normal.

Patients must have a GOG Performance Status of 0 or 1.

Patients must have recovered from the effects of surgery, radiation therapy or chemoradiotherapy. At least six weeks must have elapsed from the last administration of chemoradiotherapy, and at least three weeks must have elapsed from the last administration of radiation therapy alone.

Patients must meet all of the pre-entry requirements specified in Section 7.0 of the protocol including baseline QOL questionnaire.

Patients must be free of clinically significant infection.

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

Patients must have adequate Renal function. Serum creatinine less than or equal to 1.2 mg/dl. Pts. with a serum creatinine greater than 1.2 mg/dl but less than 1.5 mg/dl must have a 24-hour creatinine clearance determination of greater than or equal to 50cc/min to be eligible.

Exclusion Criteria:Patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage.

Patients with a serum creatinine greater than 1.2 mg/dl but less than 1.5 mg/dl with a 24-hour creatinine clearance determination of less than 50cc/min. Patients with a serum creatinine of 1.5 mg/dl or greater.

Patients previously treated with chemotherapy except when used concurrently with radiation therapy.

Patients who are pregnant or lactating.

Patients with craniospinal metastases.

Patients with a concomitant malignancy other than non-melanoma skin cancer.

Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy.

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Links
Registration Number: NCT00064077
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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