A Trial for Patients With Gestational Trophoblastic Disease

NCT00190918 | Completed Phase 2

• 2 other identifiers: 8366H3E-US-JMGR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trophoblastic Neoplasms; Uterine Neoplasms; Hydatidiform Mole; Choriocarcinoma

Outcome Measures

Primary Outcomes (1)

• To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients

Secondary Outcomes (1)

• To determine the toxicity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients

Interventions

Pemetrexed DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group 215-854-0770

Philadelphia, Pennsylvania, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Trophoblastic Neoplasms; Uterine Neoplasms; Hydatidiform Mole; Choriocarcinoma

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Genital Diseases; Gestational Trophoblastic Disease; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• David Miller, MD

  Gynecologic Oncology Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: July 1, 2006
• Study Completion: July 1, 2007
• Last Updated: August 9, 2007

Record last verified: 2007-08

Locations

US (1)