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

PHASE3CompletedINTERVENTIONAL
Enrollment

198

Participants

Timeline

Start Date

September 30, 2003

Primary Completion Date

September 30, 2008

Study Completion Date

June 30, 2009

Conditions
Neoplasms, Unknown Primary
Interventions
DRUG

Etoposide

50 mg alternating with 100 mg PO, days 1 and 10 in regimen A

DRUG

Gemcitabine

1000 mg/m2 IV, days 1 and 8, in regimen B

DRUG

Irinotecan

1000 mg/m2 IV days 1 and 8 in regimen B

DRUG

Paclitaxel

200 mg/m2 by 1-hour IV infusion, day 1, regimen A

DRUG

Carboplatin

Area under the curve (AUC) 6.0 IV, day 1, regimen A

Trial Locations (31)

19026

Consultants in Medical Oncology and Hematology, Drexel Hill

19612

Reading Hospital Regional Cancer Center, West Reading

24211

Cancer Outreach Associates, Abingdon

29303

Spartanburg Regional Medical Center, Spartanburg

30060

Wellstar Cancer Research, Marietta

30501

Northeast Georgia Medical Center, Gainesville

31701

Phoebe Cancer Center, Albany

32804

Florida Hospital Cancer Institute, Orlando

33133

Mercy Hospital Miami, Miami

33805

Watson Clinic Center for Cancer Care and Research, Lakeland

35805

Clearview Cancer Institute, Huntsville

36207

Northeast Alabama Regional Medical Center, Anniston

36608

Southern Cancer Center, Sacred Heart Heath System Medical Oncology Group, Mobile

37023

Tennessee Oncology, PLLC, Nashville

37660

Kingsport Hematology-Oncology, Kingsport

37916

Thompson Cancer Survival Center, Knoxville

39202

Jackson Oncology Associates, Jackson

40207

Consultants in Blood Disorders and Cancer, Louisville

42101

Graves-Gilbert Clinic, Bowling Green

44710

Aultman Hospital, Canton

45242

Oncology Hematology Care, Cincinnati

47714

Oncology Hematology Associates of SW Indiana, Evansville

48341

St. Joseph Mercy Oakland Hospital, Cancer Center, Pontiac

49503

Grand Rapids Clinical Oncology Program, Grand Rapids

59802

Montana Cancer Institute Foundation, Missoula

68114

Methodist Cancer Center, Omaha

70360

Terrebonne General Medical Center, Houma

72401

Northeast Arkansas Clinic, Jonesboro

78258

South Texas Oncology and Hematology, San Antonio

90211

Tower Oncology, Beverly Hills

04101

Mercy Hospital, Portland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Pharmacia and Upjohn

INDUSTRY

collaborator

Eli Lilly and Company

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER