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

Tracking Information
First Received Date ^ICMJE	March 3, 2003
Last Updated Date	September 13, 2006
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00055432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Gemzar (Gemcitabine) and Alimta (Pemetrexed) in the Treatment of Patients With Recurrent Platinum-Sensitive and Platinum-Resistant Ovarian or Peritoneal Cancer
Official Title ^ICMJE
Brief 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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Condition ^ICMJE	Ovarian Cancer Peritoneal Cancer
Intervention ^ICMJE	Drug: Gemzar and Alimta
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00055432
Responsible Party
Study ID Numbers ^ICMJE	7127, H3E-US-JMFU
Study Sponsor ^ICMJE	Eli Lilly and Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eli Lilly and Company
Verification Date	September 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP