- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00055432
Gemzar (Gemcitabine) and Alimta (Pemetrexed) in the Treatment of Patients With Recurrent Platinum-Sensitive and Platinum-Resistant Ovarian or Peritoneal Cancer
September 13, 2006 updated by: Eli Lilly and Company
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
March 3, 2003
First Submitted That Met QC Criteria
March 3, 2003
First Posted (Estimate)
March 4, 2003
Study Record Updates
Last Update Posted (Estimate)
September 15, 2006
Last Update Submitted That Met QC Criteria
September 13, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Folic Acid Antagonists
- Gemcitabine
- Pemetrexed
Other Study ID Numbers
- 7127
- H3E-US-JMFU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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