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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
Est. completion date
Est. primary completion date
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


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, 

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