Clinical trial NCT00193596: Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neoplasms, Unknown Primary
Keywords: Neoplasms, Unknown Primary
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Pharmacia and Upjohn
name: Eli Lilly and Company
First posted: 2005-09-19
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
timeFrame: 24 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Northeast Alabama Regional Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group
state: Alabama
city: Jonesboro
country: United States
facility: Northeast Arkansas Clinic
state: Arkansas
city: Beverly Hills
country: United States
facility: Tower Oncology
state: California
city: Lakeland
country: United States
facility: Watson Clinic Center for Cancer Care and Research
state: Florida
city: Miami
country: United States
facility: Mercy Hospital Miami
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Albany
country: United States
facility: Phoebe Cancer Center
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Marietta
country: United States
facility: Wellstar Cancer Research
state: Georgia
city: Evansville
country: United States
facility: Oncology Hematology Associates of SW Indiana
state: Indiana
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic
state: Kentucky
city: Louisville
country: United States
facility: Consultants in Blood Disorders and Cancer
state: Kentucky
city: Houma
country: United States
facility: Terrebonne General Medical Center
state: Louisiana
city: Portland
country: United States
facility: Mercy Hospital
state: Maine
city: Grand Rapids
country: United States
facility: Grand Rapids Clinical Oncology Program
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland Hospital, Cancer Center
state: Michigan
city: Jackson
country: United States
facility: Jackson Oncology Associates
state: Mississippi
city: Missoula
country: United States
facility: Montana Cancer Institute Foundation
state: Montana
city: Omaha
country: United States
facility: Methodist Cancer Center
state: Nebraska
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Drexel Hill
country: United States
facility: Consultants in Medical Oncology and Hematology
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital Regional Cancer Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Kingsport
country: United States
facility: Kingsport Hematology-Oncology
state: Tennessee
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Oncology and Hematology
state: Texas
city: Abingdon
country: United States
facility: Cancer Outreach Associates
state: Virginia
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hainsworth JD, Spigel DR, Clark BL, Shipley D, Thompson DS, Farley C, West-Osterfield K, Lane CM, Cescon T, Bury MJ, Greco FA. Paclitaxel/carboplatin/etoposide versus gemcitabine/irinotecan in the first-line treatment of patients with carcinoma of unknown primary site: a randomized, phase III Sarah Cannon Oncology Research Consortium Trial. Cancer J. 2010 Jan-Feb;16(1):70-5. doi: 10.1097/PPO.0b013e3181c6aa89.