A Randomized Trial for Patients With Platinum Resistant Ovarian, Fallopian or Primary Peritoneal Cancer.

Study Description

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Brief Summary:

This trial compares two chemotherapy agents for the treatment of recurrent ovarian, fallopian or primary peritoneal cancer in patients that have received and are no longer responding to Platinum based treatment. The purpose of this trial is to compare progression free survival between gemcitabine and liposomal doxorubicin. Progression free survival (PFS) is defined as the period from study entry until disease progression

Condition or disease	Intervention/treatment	Phase
Genital Neoplasms, Female; Fallopian Tube Neoplasms; Ovarian Neoplasms; Pelvic Neoplasms; Peritoneal Neoplasms	Drug: Gemcitabine; Drug: liposomal doxorubicin	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	162 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized Phase III Trial of Gemzar Versus Doxil With Crossover Treatment Option for Patients With Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer Undergoing Second or Third-Line Chemotherapy
Study Start Date :	July 2002
Study Completion Date :	November 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. - Progression free survival (PFS) in patients who have failed one, but no more than two, prior treatments

Secondary Outcome Measures :

1. Secondary objectives:
2. Response rate
3. Duration of response
4. Time to treatment failure
5. Survival
6. Quality of life

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• All patients must have a documented pathologic diagnosis of epithelial ovarian (FIGO Stage I-IV), Fallopian tube or primary peritoneal carcinoma
• Patients must have received platinum-based, first-line chemotherapy but no more than one additional prior chemotherapy regimen. Patients must have recovered from the acute side effects of prior chemotherapy prior to enrollment in this trial.
• Patients must be considered to have platinum resistant disease based on the most recent platinum-based regimen given, i.e., have had a treatment-free interval in response to platinum of less than six months, or have progressed during platinum-based therapy
• Presence of measurable disease or CA-125 > or = to 100 on two separate occasions at least one week apart is required for this study
• Patient must have a Zubrod Performance Status of 0, 1 or 2

Exclusion

• Patients with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible. Patients with a prior diagnosis of a low malignant potential tumor that was surgically resected and who have subsequently developed invasive adenocarcinoma are eligible.
• Patients who are currently undergoing abdominal or pelvic radiation therapy or patients who have received prior abdominal or pelvic radiation therapy are excluded.
• Patients with unstable angina or who have had a heart attack within the past six months are not eligible to participate.
• Patients who have received prior Gemzar or Doxil therapy are ineligible.

Contacts and Locations

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Locations

United States, Missouri
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:	CALL 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 MON-FRI 9AM-5PM Eastern Time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00191607 History of Changes
Other Study ID Numbers:	6890; B9E-US-S301
First Posted:	September 19, 2005
Last Update Posted:	January 26, 2007
Last Verified:	January 2007

Additional relevant MeSH terms:

Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms; Genital Neoplasms, Female; Pelvic Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Abdominal Neoplasms	Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Fallopian Tube Diseases; Gemcitabine; Doxorubicin; Liposomal doxorubicin; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents