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Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

Primary Purpose

Good Prognosis Metastatic Gestational Trophoblastic Tumor, Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dactinomycin
Methotrexate
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Good Prognosis Metastatic Gestational Trophoblastic Tumor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (methotrexate)

Arm II (dactinomycin)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay
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
Number of participants with a maximum grade of 3 or higher during the treatment period.

Secondary Outcome Measures

Number of Patients With a Decline of hCG 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.

Full Information

First Posted
November 1, 1999
Last Updated
April 12, 2018
Sponsor
Gynecologic Oncology Group
Collaborators
Eastern Cooperative Oncology Group, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003702
Brief Title
Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
Official Title
A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
Eastern Cooperative Oncology Group, National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Good Prognosis Metastatic Gestational Trophoblastic Tumor, Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor, Uterine Corpus Choriocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (methotrexate)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (dactinomycin)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Dactinomycin
Other Intervention Name(s)
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
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
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
Intervention Description
Given intramuscularly
Primary Outcome Measure Information:
Title
Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay
Description
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.
Time Frame
Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.
Title
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0
Description
Number of participants with a maximum grade of 3 or higher during the treatment period.
Time Frame
Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.
Secondary Outcome Measure Information:
Title
Number of Patients With a Decline of hCG on Day 1 of Treatment
Description
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.
Time Frame
Prior to study entry and on Day 1 of treatment

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Osborne
Organizational Affiliation
Gynecologic Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gynecologic Oncology Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

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Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

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