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

NCT00055432 | Terminated Phase 2

• 2 other identifiers: 7127H3E-US-JMFU
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Peritoneal Cancer

Keywords

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

Interventions

Gemzar and Alimta DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Gemcitabine; Pemetrexed

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 3, 2003
• First Posted: March 4, 2003
• Last Updated: September 15, 2006

Record last verified: 2006-09

Locations

US (1)