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

SCRI Development Innovations

Status and phase: Completed; Phase 3

Conditions: Neoplasms, Unknown Primary

Treatments: Drug: Irinotecan; Drug: Etoposide; Drug: Carboplatin; Drug: Gemcitabine; Drug: Paclitaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193596

SCRI UNKPRI 12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Regimen A

Experimental group

Description:

Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: Etoposide

Regimen B

Experimental group

Description:

Irinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B was repeated at a 21-day interval

Treatment:

Drug: Gemcitabine

Drug: Irinotecan