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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

This study has been terminated.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00055432
First received: March 3, 2003
Last updated: September 13, 2006
Last verified: September 2006
  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 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 20, 2014