Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00193596 |
|
Recruitment Status :
Completed
First Posted : September 19, 2005
Results First Posted : May 3, 2013
Last Update Posted : May 3, 2013
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neoplasms, Unknown Primary | Drug: Etoposide Drug: Gemcitabine Drug: Irinotecan Drug: Paclitaxel Drug: Carboplatin | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 198 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | September 2003 |
| Actual Primary Completion Date : | September 2008 |
| Actual Study Completion Date : | June 2009 |
| Arm | Intervention/treatment |
|---|---|
|
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 |
- 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.
- 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193596
Show 31 study locations
| Principal Investigator: | John D. Hainsworth, MD | SCRI Development Innovations, LLC |
Publications of Results:
| Responsible Party: | SCRI Development Innovations, LLC |
| ClinicalTrials.gov Identifier: | NCT00193596 |
| Other Study ID Numbers: |
SCRI UNKPRI 12 |
| First Posted: | September 19, 2005 Key Record Dates |
| Results First Posted: | May 3, 2013 |
| Last Update Posted: | May 3, 2013 |
| Last Verified: | March 2013 |
|
Neoplasms, Unknown Primary |
|
Neoplasms, Unknown Primary Neoplasms Neoplasm Metastasis Neoplastic Processes Pathologic Processes Gemcitabine Paclitaxel Etoposide Carboplatin Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Topoisomerase II Inhibitors |