A Trial for Patients With Gestational Trophoblastic Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-07-31

Brief Summary

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This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.

Detailed Description

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Conditions

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Trophoblastic Neoplasms Uterine Neoplasms Hydatidiform Mole Choriocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pemetrexed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT)
* WHO score 2-6 (re-evaluated at the time of relapse
* Histologically confirmed complete or partial moles on initial evacuation
* Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
* All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
* Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
* Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy.

Exclusion Criteria

* Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/- folinic acid).
* Patients with more than 8 metastatic lesions identified
* Patients with metastases to liver, spleen, brain, kidney or GI tract

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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David Miller, MD

Role: STUDY_CHAIR

Gynecologic Oncology Group

Locations

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Gynecologic Oncology Group 215-854-0770

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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H3E-US-JMGR

Identifier Type: -

Identifier Source: secondary_id

8366