Gemzar (Gemcitabine) and Alimta (Pemetrexed) in the Treatment of Patients With Recurrent Platinum-Sensitive and Platinum-Resistant Ovarian or Peritoneal Cancer

Ovarian Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00055432
• Other study ID #: 7127
• Secondary ID: H3E-US-JMFU
• Status: Terminated
• Phase: Phase 2
• First received: March 3, 2003
• Last updated: September 13, 2006

Study information

• Verified date: September 2006
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study hopes to evaluate whether the combination of Gemzar plus Alimta will have any beneficial effects for patients with recurrent platinum-sensitive or platinum-resistant ovarian or peritoneal cancer. Treatments are weekly for two weeks, with the 3rd week off and will be repeated every 21 days. Side effects and the overall safety of the treatment will also be monitored and evaluated. In addition, a Quality of Life questionnaire is part of this study to help measure patient perceived benefits or drawbacks to this treatment regimen.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have disease that can be measured.

• Patients must meet criteria for either platinum-resistant or platinum-sensitive ovarian or peritoneal cancer.

• Patients may only have had one prior platinum-based chemotherapy regimen.

• Patients must be willing and able to stop all aspirin and NSAID medications immediately before and for a time after each treatment cycle (approx. 5-8 days)

• Patients must have normal kidney function.

Exclusion Criteria:

• Patients may not have a Low Malignant Potential or Borderline Ovarian Tumor.

• Patients may not have received pelvic or abdominal radiotherapy.

• Patients must not have evidence of or received treatment for another cancer within the last 5 years.

• Patients must not have been diagnosed with a heart attack in the last 6 months.

• Patients who are unwilling or unable to take folic acid tablets, vitamin B12 injections or dexamethasone tablets.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• Gemzar and Alimta

Locations

Country	Name	City	State
United States	For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States,