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Completed

NCT Number: NCT00193596

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

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.

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Key information

Conditions

Neoplasms, Unknown Primary Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Northeast Alabama Regional Medical Center, Anniston, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

etoposide

Drug

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

Other names: Etopophos, Toposar

Gemcitabine

Drug

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

Other names: Gemzar

Irinotecan

Drug

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

Other names: Camptosar

paclitaxel

Drug

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

Other names: Abraxane

carboplatin

Drug

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

Other names: Paraplatin

Primary outcomes

  1. Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    Time frame: 24 months

    Length of time, in months, that patients were alive from their first date of protocol treatment until death.

Secondary outcomes

  1. 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

    Time frame: 12 months

    Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • AstraZeneca
  • Eli Lilly and Company
  • Pharmacia and Upjohn

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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