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Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site

Information source: SCRI Development Innovations, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasms, Unknown Primary

Intervention: Etoposide (Drug); Gemcitabine (Drug); Irinotecan (Drug); Paclitaxel (Drug); Carboplatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: SCRI Development Innovations, LLC

Official(s) and/or principal investigator(s):
John D. Hainsworth, MD, Principal Investigator, Affiliation: SCRI Development Innovations, LLC

Summary

In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.

Clinical Details

Official title: A Randomized, Phase III Comparison of Gemcitabine/Irinotecan Followed by IRESSA Versus Paclitaxel/Carboplatin/Etoposide Followed by IRESSA in the First-Line Treatment of Patients With Carcinoma of Unknown Primary Site

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

Secondary outcome: Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

Detailed description: Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:

- Paclitaxel + Carboplatin + Etoposide

- Irinotecan + Gemcitabine

Patients will be stratified by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression. Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: To be included in this study, you must meet the following criteria:

- Carcinoma of unknown primary site

- Biopsy-proven metastatic carcinoma

- Able to perform activities of daily living with minimal assistance

- No previous treatment with any systemic therapy

- Measurable or evaluable disease

- Adequate bone marrow, liver and kidney function

- Understand the nature of this study and give written informed consent

Exclusion Criteria: You cannot participate in this study if any of the following apply to you:

- Age < 18 years

- Uncontrolled brain metastases and meningeal involvement

- Other uncontrolled malignancies

- Women pregnant or lactating

- Recent history of significant cardiovascular disease

- Severe or uncontrolled systemic disease

- Other significant clinical disorder

- Clinically active interstitial lung disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Locations and Contacts

Northeast Alabama Regional Medical Center, Anniston, Alabama 36207, United States

Clearview Cancer Institute, Huntsville, Alabama 35805, United States

Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group, Mobile, Alabama 36608, United States

Northeast Arkansas Clinic, Jonesboro, Arkansas 72401, United States

Tower Oncology, Beverly Hills, California 90211, United States

Watson Clinic Center for Cancer Care and Research, Lakeland, Florida 33805, United States

Mercy Hospital Miami, Miami, Florida 33133, United States

Florida Hospital Cancer Institute, Orlando, Florida 32804, United States

Phoebe Cancer Center, Albany, Georgia 31701, United States

Northeast Georgia Medical Center, Gainesville, Georgia 30501, United States

Wellstar Cancer Research, Marietta, Georgia 30060, United States

Oncology Hematology Associates of SW Indiana, Evansville, Indiana 47714, United States

Graves-Gilbert Clinic, Bowling Green, Kentucky 42101, United States

Consultants in Blood Disorders and Cancer, Louisville, Kentucky 40207, United States

Terrebonne General Medical Center, Houma, Louisiana 70360, United States

Mercy Hospital, Portland, Maine 04101, United States

Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan 49503, United States

St. Joseph Mercy Oakland Hospital, Cancer Center, Pontiac, Michigan 48341, United States

Jackson Oncology Associates, Jackson, Mississippi 39202, United States

Montana Cancer Institute Foundation, Missoula, Montana 59802, United States

Methodist Cancer Center, Omaha, Nebraska 68114, United States

Aultman Hospital, Canton, Ohio 44710, United States

Oncology Hematology Care, Cincinnati, Ohio 45242, United States

Consultants in Medical Oncology and Hematology, Drexel Hill, Pennsylvania 19026, United States

Reading Hospital Regional Cancer Center, West Reading, Pennsylvania 19612, United States

Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States

Kingsport Hematology-Oncology, Kingsport, Tennessee 37660, United States

Thompson Cancer Survival Center, Knoxville, Tennessee 37916, United States

Tennessee Oncology, PLLC, Nashville, Tennessee 37023, United States

South Texas Oncology and Hematology, San Antonio, Texas 78258, United States

Cancer Outreach Associates, Abingdon, Virginia 24211, United States

Additional Information

Published article in The Cancer Journal

Starting date: September 2003
Last updated: March 22, 2013

Page last updated: August 23, 2015

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