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Trial record 2 of 3 for:    "Hydatidiform Mole, Recurrent, 1" | "Antimetabolites"

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
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Good Prognosis Metastatic Gestational Trophoblastic Tumor
Hydatidiform Mole
Non-Metastatic Gestational Trophoblastic Tumor
Uterine Corpus Choriocarcinoma
Interventions Biological: Dactinomycin
Drug: Methotrexate
Enrollment 240
Recruitment Details This trial opened to patient accrual on 6/14/1999 and closed to accrual on 2/26/2007.
Pre-assignment Details  
Arm/Group Title Arm 1: Methotrexate 30 mg/m2 IM Weekly Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
Hide Arm/Group Description Arm 1: Methotrexate 30 mg/m2 IM weekly Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
Period Title: Overall Study
Started 120 120
Completed 107 109
Not Completed 13 11
Reason Not Completed
Ineligible cell types             2             2
Did not meet criteria for persistence             8             5
WHO score > 6             2             1
Inadequate documentation of disease             1             3
Arm/Group Title Arm 1: Methotrexate 30 mg/m2 IM Weekly Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks Total
Hide Arm/Group Description Arm 1: Methotrexate 30 mg/m2 IM weekly Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks Total of all reporting groups
Overall Number of Baseline Participants 107 109 216
Hide Baseline Analysis Population Description
Eligible participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 109 participants 216 participants
28.8  (7.9) 30.4  (8.6) 29.6  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 109 participants 216 participants
Female
107
 100.0%
109
 100.0%
216
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received a random treatment allocation
Arm/Group Title Arm 1: Methotrexate 30 mg/m2 IM Weekly Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
Hide Arm/Group Description:
Arm 1: Methotrexate 30 mg/m2 IM weekly
Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
Overall Number of Participants Analyzed 107 109
Measure Type: Count of Participants
Unit of Measure: Participants
Complete/Cure 57 76
Non-response 48 29
Inevaluable 2 4
2.Primary Outcome
Title Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Arm 1: Methotrexate 30 mg/m2 IM Weekly Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
Hide Arm/Group Description:
Arm 1: Methotrexate 30 mg/m2 IM weekly
Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
Overall Number of Participants Analyzed 107 109
Measure Type: Count of Participants
Unit of Measure: Participants
14
  13.1%
20
  18.3%
3.Secondary Outcome
Title Number of Patients With a Decline of hCG on Day 1 of Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluated patients
Arm/Group Title Enrolled Participants
Hide Arm/Group Description:
Enrolled participants that had a subsequent hCG measurement after enrollment and before treatment
Overall Number of Participants Analyzed 178
Measure Type: Count of Participants
Unit of Measure: Participants
72
Time Frame Through Study completion, an average of 7 months.
Adverse Event Reporting Description The frequencies of any serious adverse event or other adverse events (grade 2 or higher) by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported. Adverse events were collected by Organ System Class.
 
Arm/Group Title Arm 1: Methotrexate 30 mg/m2 IM Weekly Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
Hide Arm/Group Description Arm 1: Methotrexate 30 mg/m2 IM weekly Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
All-Cause Mortality
Arm 1: Methotrexate 30 mg/m2 IM Weekly Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Methotrexate 30 mg/m2 IM Weekly Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)   1/107 (0.93%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  0/107 (0.00%)  1/107 (0.93%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Methotrexate 30 mg/m2 IM Weekly Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   50/107 (46.73%)   68/107 (63.55%) 
Blood and lymphatic system disorders     
Leukopenia * 1  3/107 (2.80%)  7/107 (6.54%) 
Neutropenia * 1  6/107 (5.61%)  20/107 (18.69%) 
Thrombocytopenia * 1  2/107 (1.87%)  1/107 (0.93%) 
Anemia * 1  7/107 (6.54%)  14/107 (13.08%) 
Other Hemotologic * 1  0/107 (0.00%)  1/107 (0.93%) 
Hemorrhage * 1  9/107 (8.41%)  13/107 (12.15%) 
Cardiac disorders     
Cardiovascular * 1  0/107 (0.00%)  2/107 (1.87%) 
Ear and labyrinth disorders     
Auditory * 1  1/107 (0.93%)  1/107 (0.93%) 
Endocrine disorders     
Endocrine * 1  0/107 (0.00%)  2/107 (1.87%) 
Eye disorders     
Ocular/Visual * 1  5/107 (4.67%)  4/107 (3.74%) 
Gastrointestinal disorders     
Gastrointestinal * 1  7/107 (6.54%)  14/107 (13.08%) 
Nausea * 1  8/107 (7.48%)  21/107 (19.63%) 
Vomiting * 1  3/107 (2.80%)  14/107 (13.08%) 
Diarrhea * 1  2/107 (1.87%)  1/107 (0.93%) 
Stomatitis * 1  5/107 (4.67%)  1/107 (0.93%) 
General disorders     
Constitutional * 1  12/107 (11.21%)  15/107 (14.02%) 
Pain * 1  13/107 (12.15%)  14/107 (13.08%) 
Hepatobiliary disorders     
Hepatic * 1  2/107 (1.87%)  3/107 (2.80%) 
Immune system disorders     
Allergy * 1  2/107 (1.87%)  0/107 (0.00%) 
Infections and infestations     
Infection/Fever * 1  7/107 (6.54%)  4/107 (3.74%) 
Metabolism and nutrition disorders     
Metabolic * 1  0/107 (0.00%)  2/107 (1.87%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal * 1  1/107 (0.93%)  0/107 (0.00%) 
Nervous system disorders     
Neurologic * 1  6/107 (5.61%)  5/107 (4.67%) 
Renal and urinary disorders     
Genitourinary/Renal * 1  3/107 (2.80%)  0/107 (0.00%) 
Reproductive system and breast disorders     
Sexual * 1  1/107 (0.93%)  1/107 (0.93%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary * 1  0/107 (0.00%)  8/107 (7.48%) 
Skin and subcutaneous tissue disorders     
Dermatologic * 1  1/107 (0.93%)  0/107 (0.00%) 
Vascular disorders     
Coagulation * 1  1/107 (0.93%)  0/107 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Angela M. Kuras on behalf of Virginia Filiaci
Organization: NRG Oncology
Phone: 7168455702
EMail: kurasa@nrgoncology.org
Layout table for additonal information
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00003702     History of Changes
Other Study ID Numbers: GOG-0174
NCI-2011-02026 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ECOG-G174
CDR0000066809
GOG-0174 ( Other Identifier: Gynecologic Oncology Group )
GOG-0174 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: November 2, 2017
Results First Posted: May 15, 2018
Last Update Posted: May 15, 2018