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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Merck |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00769483 |
Purpose
Objectives:
Primary Objectives:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer Pancreatic Adenocarcinoma |
Drug: MK-0646 Drug: Gemcitabine Drug: Erlotinib |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/ Randomized Phase II Study of Gemcitabine Plus Erlotinib Plus MK-0646; Gemcitabine Plus MK-0646 and Gemcitabine Plus Erlotinib for Patients With Advanced Pancreatic Cancer (IISP#33337) |
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phase I, Arm A
MK-0646 + Gemcitabine
|
Drug: MK-0646
Starting Dose Level: 5 mg/kg given intravenously over 60 minutes Days 1, 8, 15, 22 of 28 Day Cycle.
Drug: Gemcitabine
1000 mg/m^2 given intravenously over 1-1/2 hours Days 1, 8, and 15 of each 28 Day Cycle.
Other Names:
|
|
Experimental: Phase I, Arm B
MK-0646 + Gemcitabine + Erlotinib
|
Drug: MK-0646
Starting Dose Level: 5 mg/kg given intravenously over 60 minutes Days 1, 8, 15, 22 of 28 Day Cycle.
Drug: Gemcitabine
1000 mg/m^2 given intravenously over 1-1/2 hours Days 1, 8, and 15 of each 28 Day Cycle.
Other Names:
Drug: Erlotinib
100 mg by mouth daily.
Other Names:
|
|
Experimental: Phase II, Arm A
Gemcitabine + Erlotinib
|
Drug: MK-0646
Starting Dose Level: 5 mg/kg given intravenously over 60 minutes Days 1, 8, 15, 22 of 28 Day Cycle.
Drug: Gemcitabine
1000 mg/m^2 given intravenously over 1-1/2 hours Days 1, 8, and 15 of each 28 Day Cycle.
Other Names:
|
|
Experimental: Phase II, Arm B
MK-0646 + Gemcitabine + Erlotinib
|
Drug: MK-0646
Starting Dose Level: 5 mg/kg given intravenously over 60 minutes Days 1, 8, 15, 22 of 28 Day Cycle.
Drug: Gemcitabine
1000 mg/m^2 given intravenously over 1-1/2 hours Days 1, 8, and 15 of each 28 Day Cycle.
Other Names:
Drug: Erlotinib
100 mg by mouth daily.
Other Names:
|
|
Experimental: Phase II, Arm C
Gemcitabine + Erlotinib
|
Drug: Gemcitabine
1000 mg/m^2 given intravenously over 1-1/2 hours Days 1, 8, and 15 of each 28 Day Cycle.
Other Names:
Drug: Erlotinib
100 mg by mouth daily.
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Milind Javle, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00769483 History of Changes |
| Other Study ID Numbers: | 2007-0910 |
| Study First Received: | October 8, 2008 |
| Last Updated: | May 16, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
|
Pancreas Pancreatic Cancer Advanced cancer of the pancreas Pancreatic Adenocarcinoma MK-0646 Gemcitabine |
Gemzar Erlotinib hydrochloride Erlotinib OSI-774 Tarceva |
|
Adenocarcinoma Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Erlotinib |
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 Protein Kinase Inhibitors |