Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Not specified NCI GOG-174 ECOG-G174, GOG-0174, NCT00003702

Objectives

1. Compare the efficacy of methotrexate vs dactinomycin, as measured by complete response rate, in patients with low-risk gestational trophoblastic neoplasia.
2. Compare the toxicity of these regimens in these patients.
3. Determine whether the definition of persistent gestational trophoblastic neoplasia is accurate (as determined by the likelihood that the beta human chorionic gonadotropin [HCG] titer would decline on the day treatment is initiated).

Entry Criteria

Disease Characteristics:

• Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:
  • Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers
  • Greater than 20% sustained rise in beta HCG titer over two consecutive weeks
  • Persistently elevated beta HCG titer more than 4 months after initial curettage (greater than 5 mIU/mL minimum)
  • Histologically proven nonmetastatic choriocarcinoma
  • Metastases to vagina, parametria, or lung (if no single pulmonary lesion is greater than 2 cm)



• WHO score 0-6 (not including blood group or CT lung)



• No histologically confirmed placental site pseudotumor



• Must have undergone at least 1 uterine curettage



• Previously untreated disease

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for gestational trophoblastic neoplasia

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics
• No concurrent curettage except as needed to control vaginal bleeding or to rule out placental site pseudotumor

Patient Characteristics:

Age:

• Not specified

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGPT and SGOT no greater than 3 times ULN
• Alkaline phosphatase no greater than 3 times ULN
• No significant prior abnormal hepatic function

Renal:

• Creatinine no greater than 2.0 mg/dL
• No significant prior abnormal renal function

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for one year after study entry
• No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer

Expected Enrollment

A total of 216 patients will be accrued for this study within 4 years.

Outcomes

Frequency of objective (complete) response as measured by normal beta human chorionic gonadotropin (HCG) levels
Frequency and severity of observed adverse effects

Cure rate as measured by normal beta HCG levels

Outline

This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity.



• Arm II: Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity.

All patients continue on treatment until 1 beta human chorionic gonadotropin (HCG) titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.

Patients are followed every 4 weeks for 1 year.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Raymond Osborne, MD, FRCSC, MBA, Protocol chair		Ph: 416-480-4026 Email: ray.osbourne@sw.ca

Eastern Cooperative Oncology Group

Higinia Cardenes, MD, PhD, Protocol chair		Ph: 317-274-2524; 888-600-4822 Email: hcardene@iupui.edu

Registry Information
Official Title		A Randomized Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Manangement for Low Risk Gestational Trophoblastic Neoplasia
Trial Start Date		1999-06-14
Trial Completion Date		2003-02-17 (estimated)
Registered in ClinicalTrials.gov		NCT00003702
Date Submitted to PDQ		1998-12-16
Information Last Verified		2007-08-07
NCI Grant/Contract Number		CA27469

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