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Study Summary
No. GOG 0174:.......Gynecology......Lois M. Ramondetta......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:		GOG 0174
Study Title:A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia
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Physician New Patient Referral
Name:Lois M. RamondettaPatients 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:713-745-0307
Contact us about clinical trials
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General Information
Disease Group:GynecologySupported By:Gynecologic Oncology Group
Phase of Study:Phase IIIReturn
Visit:		Either Regimen - weekly for 4 weeks, then monthly for 12 months
Treatment
Agents:		Collection
Methotrexate
Dactinomycin		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:05/18/2004
IRB Review and Approval Date:03/17/2004
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:48
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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 with untreated, histologically confirmed low risk GTN (persistent hydatidiform mole or choriocarcinoma). See protocol section 3.1 for definition of GTN.

Patients with a pretreatment World Health Organization (WHO) score of 0 to 6 (NOT including blood group and CT lung). (Appendix I).

Patients with adequate bone marrow, hepatic and renal function: WBC equal to or greater than 3,000 cells/mcl- Granulocytes equal to or greater than 1500/mcl- Platelets equal to or greater than 100,000/mcl- Creatinine equal to or less than 2.0 mg/dcl- Bilirubin equal to or less than 1.5x institutional normal- SGPT, SGOT and alkaline phosphatase equal to or less than 3x institutional normal.

Patients must have signed an approved informed consent.

Patients with a GOG Performance Status 0, 1, or 2.

Patients must meet the pre-entry requirements specified in section 7.0.

Patients must practice effective contraception for the duration of the study (Section 4.13).
Exclusion Criteria:Patients with histologically confirmed placental site pseudotumor (PSTT).

Patients who have received any prior chemotherapy for any occurrence of GTN.

Patients who will not agree to practice effective contraception for the duration of the study.

Patients with metastatic disease. (Patients with lung metastases less than 2 cm in size or vaginal/parametrial metastases are eligible.)

Patients who wish to continue breast-feeding during treatment.

Patients with significant pre-existing abnormal liver and/or renal function.

Patients with other invasive malignancies, excluding non-melanoma skin cancer, who have not been disease-free for a minimum of last 5 years, or whose previous cancer therapy contraindicates this protocol therapy.
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Links
Registration Number: NCT00003702
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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