Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

NCT ID: NCT00003702

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-30

Brief Summary

Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.

Detailed Description

OBJECTIVES:

I. Compare the efficacy of methotrexate vs dactinomycin, as measured by complete response rate, in patients with low-risk gestational trophoblastic neoplasia.

II. Compare the toxicity of these regimens in these patients. III. 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).

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.

Conditions

Good Prognosis Metastatic Gestational Trophoblastic Tumor; Hydatidiform Mole; Non-Metastatic Gestational Trophoblastic Tumor; Uterine Corpus Choriocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I (methotrexate)

Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

Given intramuscularly

Arm II (dactinomycin)

Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.

Group Type: EXPERIMENTAL

Dactinomycin

Intervention Type: BIOLOGICAL

Given IV

Interventions

Dactinomycin

Given IV

Intervention Type: BIOLOGICAL

Methotrexate

Given intramuscularly

Intervention Type: DRUG

Other Intervention Names

Actinomycin A IV; Actinomycin C1; ACTINOMYCIN D; Actinomycin I1; Actinomycin IV; Actinomycin X 1; Actinomycin-[thr-val-pro-sar-meval]; Cosmegen; DACT; Dactinomycine; Lyovac Cosmegen; Meractinomycin; Abitrexate; Alpha-Methopterin; Amethopterin; Brimexate; CL 14377; CL-14377; Emtexate; Emthexat; Emthexate; Farmitrexat; Fauldexato; Folex; Folex PFS; Lantarel; Ledertrexate; Lumexon; Maxtrex; Medsatrexate; Metex; Methoblastin; Methotrexate LPF; Methotrexate Methylaminopterin; Methotrexatum; Metotrexato; Metrotex; Mexate; Mexate-AQ; MTX; Novatrex; Rheumatrex; Texate; Tremetex; Trexeron; Trixilem; WR-19039

Eligibility Criteria

Inclusion Criteria

• 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
• Performance status - GOG 0-2
• WBC at least 3,000/mm^3
• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• 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
• Creatinine no greater than 2.0 mg/dL
• No significant prior abnormal renal function
• 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
• No prior chemotherapy for gestational trophoblastic neoplasia
• No concurrent curettage except as needed to control vaginal bleeding or to rule out placental site pseudotumor

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond Osborne

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2011-02026

Identifier Type: REGISTRY

Identifier Source: secondary_id

ECOG-G174

Identifier Type: -

Identifier Source: secondary_id

CDR0000066809

Identifier Type: -

Identifier Source: secondary_id

GOG-0174

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-0174

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-0174

Identifier Type: -

Identifier Source: org_study_id