Clinical Trials Directory

Trials / Completed

CompletedNCT01001910

Pemetrexed and Carboplatin in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Phase II Trial of Combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in Platinum Sensitive Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Albert Einstein College of Medicine · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well pemetrexed disodium and carboplatin work in treating patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the response rate of combination pemetrexed (pemetrexed disodium) (Alimta) and carboplatin (Paraplatin) in recurrent ovarian, primary peritoneal, and fallopian tube carcinoma. SECONDARY OBJECTIVES: I. To evaluate the progression free interval, overall survival, and adverse effects among patients receiving this drug combination. OUTLINE: Patients receive pemetrexed disodium intravenously (IV) over 8-15 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Conditions

Interventions

TypeNameDescription
DRUGCarboplatinGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGPemetrexed DisodiumGiven IV

Timeline

Start date
2008-07-01
Primary completion
2015-01-01
Completion
2015-02-01
First posted
2009-10-27
Last updated
2024-02-28
Results posted
2021-10-20

Locations

3 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT01001910. Inclusion in this directory is not an endorsement.