NCT01535053|CompletedPhase 3ResultsDMC

Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia

A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia

GOG Foundation ClinicalTrials.gov

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6 other identifiers

GOG-0275NCI-2012-00250CDR0000725211PGOG-0275_A08PAMDREVW01U10CA180868U10CA027469

Study Type

interventional

Target

Locations

5 countries

Sites

289

Timeline

RegisteredFeb 2012

StartedJun 2012

CompletionJul 2020

Brief Summary

This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Jun 2012

Longer than P75 for phase_3

Geographic Reach

5 countries

289 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.1 years study duration

First Submitted

Initial submission to the registry

February 14, 2012

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed

4 months until next milestone

Study Start

First participant enrolled

June 18, 2012

Completed

6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

August 13, 2019

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2020

Completed

Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

6 years

First QC Date

February 14, 2012

Results QC Date

March 8, 2019

Last Update Submit

August 10, 2022

Conditions

Choriocarcinoma FIGO Stage I Gestational Trophoblastic Tumor FIGO Stage II Gestational Trophoblastic Tumor FIGO Stage III Gestational Trophoblastic Tumor Hydatidiform Mole

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Complete Response
Complete Response is defined as 3 consecutive bi-weekly values of hCG\<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml
hCG testing is performed prior to each cycle to treatment until treatment is completed, up to 10 months. For patients who have responded to treatment hCG must be obtained every 4 weeks for 1 year after completing treatment.

Secondary Outcomes (5)

Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm
Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatment
The Number of Participants With Post Protocol Surgical Treatment for Each Arm.
Anytime during post treatment follow-up for up to 2 years from study entry.
The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.
Anytime during post treatment follow-up for up to 2 years from study entry.
Patient-reported Quality of Life (QOL) at Baseline
Prior to cycle 1
Patient-reported Quality of Life (QOL) After Baseline Visit.
Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment.

Study Arms (2)

Arm I (dactinomcin)

EXPERIMENTAL

Patients receive dactinomycin IV over 15 minutes on day 1.

Biological: DactinomycinOther: Quality-of-Life Assessment

Arm II (leucovorin calcium and methotrexate)

ACTIVE COMPARATOR

Patients receive methotrexate IM on days 1, 3, 5, and 7 and leucovorin calcium PO on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.

Drug: Leucovorin CalciumDrug: MethotrexateOther: Quality-of-Life Assessment

Interventions

DactinomycinBIOLOGICAL

Given IV

Also known as: 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

Arm I (dactinomcin)

Leucovorin CalciumDRUG

Given PO

Also known as: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, Citrovorum Factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin

Arm II (leucovorin calcium and methotrexate)

MethotrexateDRUG

Given IV and IM

Also known as: 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

Arm II (leucovorin calcium and methotrexate)

Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (dactinomcin)Arm II (leucovorin calcium and methotrexate)

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma (as defined below); patients may have had a second curettage but must still meet GTN criteria below:
Post molar GTN
For the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria for GTN defined as:
A \< 10% decrease in the hCG level using as a reference the first value in the series of 4 values taken over a period of 3 weeks (\> 50 mIU/ml minimum) OR
A \> 20% sustained rise in the hCG taking as a reference the first value in the series of 3 values taken over a period of 2 weeks (\> 50 mIU/ml minimum) OR
A persistently elevated hCG level a period of 6 months or more following the initial curettage (\> 50 mIU/ml minimum)
Choriocarcinoma
Histologically proven non-metastatic choriocarcinoma OR
Histologically proven metastatic choriocarcinoma if the metastatic site(s) is restricted to one (or more) of the following: vagina, parametrium, or lung
World Health Organization (WHO) risk score 0-6
Patients must be willing to practice effective contraception for the duration of the study
White blood cell count (WBC) \>= 3,000 cells/mcL
Granulocytes \>= 1,500/mcL
Platelets \>= 100,000/mcL
Creatinine =\< 2.0 mg/dcL
+6 more criteria

You may not qualify if:

Patients who do not have GTN
Patients with non-gestational choriocarcinoma
Patients who have previously been treated with cytotoxic chemotherapy; however, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study
Patients who have received prior pelvic radiation
Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
Patients who wish to breast-feed during treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

GOG Foundationlead
National Cancer Institute (NCI)collaborator

Study Sites (289)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC