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

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ClinicalTrials.gov Identifier: NCT00055432
Recruitment Status : Terminated
First Posted : March 4, 2003
Last Update Posted : September 15, 2006
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Peritoneal Cancer Drug: Gemzar and Alimta Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00055432


Locations
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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
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ClinicalTrials.gov Identifier: NCT00055432     History of Changes
Other Study ID Numbers: 7127
H3E-US-JMFU
First Posted: March 4, 2003    Key Record Dates
Last Update Posted: September 15, 2006
Last Verified: September 2006
Keywords provided by Eli Lilly and Company:
recurrent ovarian cancer
platinum-resistant
platinum-sensitive
folate receptor antagonist
Additional relevant MeSH terms:
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Ovarian 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
Gemcitabine
Pemetrexed
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors