A Trial for Patients With Gestational Trophoblastic Disease

This study has been completed.
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190918
First received: September 12, 2005
Last updated: August 7, 2007
Last verified: August 2007
  Purpose

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.


Condition Intervention Phase
Trophoblastic Neoplasms
Uterine Neoplasms
Hydatidiform Mole
Choriocarcinoma
Drug: Pemetrexed
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

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

Estimated Enrollment: 50
Study Start Date: July 2006
Study Completion Date: July 2007
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190918

Locations
United States, Pennsylvania
Gynecologic Oncology Group 215-854-0770
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Eli Lilly and Company
Gynecologic Oncology Group
Investigators
Study Chair: David Miller, MD Gynecologic Oncology Group
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00190918     History of Changes
Other Study ID Numbers: 8366, H3E-US-JMGR
Study First Received: September 12, 2005
Last Updated: August 7, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Choriocarcinoma
Gestational Trophoblastic Disease
Hydatidiform Mole
Neoplasms
Trophoblastic Neoplasms
Uterine Neoplasms
Adenocarcinoma
Carcinoma
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Pregnancy Complications
Pregnancy Complications, Neoplastic
Urogenital Neoplasms
Uterine Diseases
Pemetrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014