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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer Peritoneal Cancer

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gemzar and Alimta

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Locations

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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

Site Status

Countries

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United States

Other Identifiers

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H3E-US-JMFU

Identifier Type: -

Identifier Source: secondary_id

7127