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

NCT00193596 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2013-05-03

Study results available
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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.

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Pharmacia and Upjohn

    collaborator INDUSTRY

  • Eli Lilly and Company

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • John D. Hainsworth, MD · SCRI Development Innovations, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2008-09-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00193596 on ClinicalTrials.gov