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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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Gemzar and Alimta

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian cancer, platinum-resistant, platinum-sensitive, folate receptor antagonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00055432

First Posted

March 3, 2003

Last Updated

September 13, 2006

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00055432

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Terminated

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Peritoneal Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Gemzar and Alimta

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

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.

City

Atlanta

State/Province

Georgia

Country

United States

Ovarian Cancer, Peritoneal Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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