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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: AstraZeneca; Eli Lilly and Company; Pharmacia and Upjohn
• Treatments: Albumin-Bound Paclitaxel; Camptothecin; Carboplatin; Etoposide; Etoposide phosphate; Gemcitabine; Irinotecan; Paclitaxel

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.