Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
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|ClinicalTrials.gov Identifier: NCT00003702|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : May 15, 2018
Last Update Posted : May 15, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Good Prognosis Metastatic Gestational Trophoblastic Tumor Hydatidiform Mole Non-Metastatic Gestational Trophoblastic Tumor Uterine Corpus Choriocarcinoma||Biological: Dactinomycin Drug: Methotrexate||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia|
|Study Start Date :||June 1999|
|Actual Primary Completion Date :||July 2010|
Experimental: 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.
Experimental: 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.
- Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay [ Time Frame: Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months. ]Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements.
- Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0 [ Time Frame: Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months. ]Number of participants with a maximum grade of 3 or higher during the treatment period.
- Number of Patients With a Decline of hCG on Day 1 of Treatment [ Time Frame: Prior to study entry and on Day 1 of treatment ]Number of patients with a decline in hCG on day 1 of treatment relative to the level at enrollment. A decline is defined as a decrease by 1 or more units between enrollment and treatment start.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003702
|United States, Pennsylvania|
|Gynecologic Oncology Group|
|Philadelphia, Pennsylvania, United States, 19103|
|Principal Investigator:||Raymond Osborne||Gynecologic Oncology Group|
|Responsible Party:||Gynecologic Oncology Group|
|Other Study ID Numbers:||
NCI-2011-02026 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0174 ( Other Identifier: Gynecologic Oncology Group )
GOG-0174 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
|First Posted:||January 27, 2003 Key Record Dates|
|Results First Posted:||May 15, 2018|
|Last Update Posted:||May 15, 2018|
|Last Verified:||February 2016|
Gestational Trophoblastic Disease
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Pregnancy Complications, Neoplastic
Female Urogenital Diseases and Pregnancy Complications
Abortifacient Agents, Nonsteroidal
Reproductive Control Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists