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

This study has been terminated.

First Received on March 3, 2003. Last Updated on September 13, 2006 History of Changes

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00055432

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer Peritoneal Cancer	Drug: Gemzar and Alimta	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055432

Locations

United States, Georgia
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, United States

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00055432 History of Changes
Other Study ID Numbers:	7127, H3E-US-JMFU
Study First Received:	March 3, 2003
Last Updated:	September 13, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

recurrent ovarian cancer
platinum-resistant
platinum-sensitive
folate receptor antagonist

Additional relevant MeSH terms:

Ovarian Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases

Peritoneal Diseases
Gemcitabine
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012