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

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Pharmacia and Upjohn
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193596
First received: September 12, 2005
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Neoplasms, Unknown Primary
Drug: Etoposide
Drug: Gemcitabine
Drug: Irinotecan
Drug: Paclitaxel
Drug: Carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Length of time, in months, that patients were alive from their first date of protocol treatment until death.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease


Enrollment: 198
Study Start Date: September 2003
Study Completion Date: June 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen A

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

Drug: Etoposide
50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
Other Names:
  • Etopophos
  • Toposar
Drug: Paclitaxel
200 mg/m2 by 1-hour IV infusion, day 1, regimen A
Other Name: Abraxane
Drug: Carboplatin
Area under the curve (AUC) 6.0 IV, day 1, regimen A
Other Name: Paraplatin
Experimental: Regimen B

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

Drug: Gemcitabine
1000 mg/m2 IV, days 1 and 8, in regimen B
Other Name: Gemzar
Drug: Irinotecan
1000 mg/m2 IV days 1 and 8 in regimen B
Other Name: Camptosar

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193596

  Show 31 Study Locations
Sponsors and Collaborators
SCRI Development Innovations, LLC
AstraZeneca
Pharmacia and Upjohn
Eli Lilly and Company
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193596     History of Changes
Other Study ID Numbers: SCRI UNKPRI 12
Study First Received: September 12, 2005
Results First Received: January 14, 2013
Last Updated: March 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by SCRI Development Innovations, LLC:
Neoplasms, Unknown Primary

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Gemcitabine
Irinotecan
Camptothecin
Etoposide
Etoposide phosphate
Carboplatin
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators

ClinicalTrials.gov processed this record on September 18, 2014