A Trial for Patients With Gestational Trophoblastic Disease
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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:
Genetics Home Reference related topics:
recurrent hydatidiform mole
Genetic and Rare Diseases Information Center resources:
Hydatidiform Mole
Gestational Trophoblastic Tumor
Choriocarcinoma
U.S. FDA Resources
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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
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:
| 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:
|
Neoplasms Choriocarcinoma Uterine Neoplasms Hydatidiform Mole Gestational Trophoblastic Disease Trophoblastic Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Pregnancy Complications, Neoplastic |
Pregnancy Complications Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on September 30, 2016