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Completed

NCT Number: NCT00190918

A Trial for Patients With Gestational Trophoblastic Disease

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Gynecologic Oncology Group 215-854-0770

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemetrexed

Drug

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Gynecologic Oncology Group

Registry information

Official study title

A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor

Important dates

Study start
2006
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Aug 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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