Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
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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 |
- 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.
- 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:
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 |
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
Show 31 Study Locations| Principal Investigator: | John D. Hainsworth, MD | Sarah Cannon Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Sarah Cannon Research Institute |
| 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 Sarah Cannon Research Institute:
|
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 Etoposide Paclitaxel Irinotecan Camptothecin Etoposide phosphate Gemcitabine Carboplatin |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Tubulin Modulators |
ClinicalTrials.gov processed this record on May 16, 2013