Good Prognosis Metastatic Gestational Trophoblastic TumorPhase 3NCT00003702

Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

A Phase 3 study testing Dactinomycin and Methotrexate in people with Good Prognosis Metastatic Gestational Trophoblastic Tumor and Hydatidiform Mole, run by Gynecologic Oncology Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Good Prognosis Metastatic Gestational Trophoblastic Tumor, Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor
What is being tested?: Dactinomycin and Methotrexate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteUnited States
Study dates: Jun 1999to Jul 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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)

Show all 25Show fewer

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Gynecologic Oncology Group
Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia

Read the detailed description

OBJECTIVES:

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
Being tested: Dactinomycin, Methotrexate
Medical subject headings: Hydatidiform Mole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DactinomycinBiological
Also called Actinomycin A IV, Actinomycin C1, ACTINOMYCIN D, Actinomycin I1
Given IV
MethotrexateDrug
Also called Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate
Given intramuscularly

Study groups in NCT00003702
Study group	Role	What they receive
Arm I (methotrexate)	Experimental	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. Receives: Drug: Methotrexate
Arm II (dactinomycin)	Experimental	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. Receives: Biological: Dactinomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.
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.
Measured: Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months.

Secondary outcomes (1)

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.
Measured: Prior to study entry and on Day 1 of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 1999Jul 2010

First posted27 Jan 2003 (estimated)
Study startJun 1999
Primary completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Good Prognosis Metastatic Gestational Trophoblastic TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00003702
Sponsor's protocol ID: GOG-0174
Other IDs: NCI-2011-02026, ECOG-G174, CDR0000066809, GOG-0174, GOG-0174, U10CA027469
Status last verified: Feb 2016
First submitted: 1 Nov 1999
Last updated: 15 May 2018
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia
ClinicalTrials.gov ID: NCT00003702
Acronym / sponsor ID: GOG-0174
Conditions: Good Prognosis Metastatic Gestational Trophoblastic Tumor, Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor, Uterine Corpus Choriocarcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Gynecologic Oncology GroupResearch network
Collaborators: Eastern Cooperative Oncology Group, National Cancer Institute (NCI)
Study start: Jun 1999
Primary completion: Jul 2010 (actual)
First posted: 27 Jan 2003 (estimated)
Results: Posted 15 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

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

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.

Patients are followed every 4 weeks for 1 year.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm I (methotrexate)	Experimental	Drug: MethotrexatePatients 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 II (dactinomycin)	Experimental	Biological: DactinomycinPatients 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.

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (25 listed)

Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:
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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DactinomycinAlso: Actinomycin A IV, Actinomycin C1, ACTINOMYCIN D, Actinomycin I1Given IV	Biological	Arm II (dactinomycin)
MethotrexateAlso: Abitrexate, Alpha-Methopterin, Amethopterin, BrimexateGiven intramuscularly	Drug	Arm I (methotrexate)

Primary outcome

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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 15 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Methotrexate 30 mg/m2 IM Weekly	120	107
Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks	120	109

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Arm 1: Methotrexate 30 mg/m2 IM Weekly n = 107	Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks n = 109
Complete/Cure	57	76
Non-response	48	29
Inevaluable	2	4

Population analysed: Eligible patients who received a random treatment allocation

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Arm 1: Methotrexate 30 mg/m2 IM Weekly n = 107	Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks n = 109
Value	14	20

Population analysed: Eligible and treated patients

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Through Study completion, an average of 7 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Methotrexate 30 mg/m2 IM Weekly	0 of 107 (0%)	50 of 107 (46.7%)	Not reported
Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks	1 of 107 (0.9%)	68 of 107 (63.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raymond Osborne principal investigator

Gynecologic Oncology Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003702.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.