Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer
This study has been completed.
Sponsor:
OSI Pharmaceuticals
Collaborator:
Criterium Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01010945
First received: November 6, 2009
Last updated: August 6, 2012
Last verified: August 2012
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Purpose
This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Pancreatic Cancer |
Drug: erlotinib Drug: gemcitabine Drug: nab-paclitaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IB Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer |
Resource links provided by NLM:
Drug Information available for:
Paclitaxel
Gemcitabine
Gemcitabine hydrochloride
Erlotinib hydrochloride
Erlotinib
U.S. FDA Resources
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Maximum Tolerated Dose [ Time Frame: Monthly (to a maximum of 12 months) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety of drug combination assessed through dose limiting toxicities (DLTs) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Safety of drug combination assessed through Adverse Events (AEs) [ Time Frame: Monthly (to a maximum of 12 months) ] [ Designated as safety issue: No ]
- Evaluate erlotinib Pharmacokinetic (PK) trough concentrations (C24h) [ Time Frame: Days 29 (Cycle 2, Day 1) and 30 ] [ Designated as safety issue: No ]
- Objective Response Rate [ Time Frame: Monthly (to a maximum of 12 months) ] [ Designated as safety issue: No ]Response will be based on the RECIST v1.1 criteria. Patients with partial and complete response will be classified as "responders".
- Progression Free Survival (PFS) [ Time Frame: Monthly (to a maximum of 12 months) ] [ Designated as safety issue: No ]PFS will be calculated as the time from start of treatment until disease progression or death; patients who are still alive and free of progression at their last follow-up will be censored at that time.
- Overall Survival [ Time Frame: Monthly (to a maximum of 12 months) ] [ Designated as safety issue: No ]Survival will be calculated as the time from start of treatment until death of any cause, patients who are still alive at their last follow-up will be censored at that time.
| Enrollment: | 19 |
| Study Start Date: | December 2009 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: erlotinib, gemcitabine, nab-paclitaxel |
Drug: erlotinib
administered orally
Other Names:
Drug: gemcitabine
administered intravenously
Drug: nab-paclitaxel
administered intravenously
|
Detailed Description:
This is a single-arm, phase 1b study to determine the maximum tolerated dose (MTD) of the combination of erlotinib (daily), gemcitabine (weekly), nab-paclitaxel (weekly) in patients with advanced pancreatic cancer.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
- Predicted life expectancy of >= 12 weeks
- Previous surgery
- Histologically or cytologically confirmed, measurable, locally advanced, unresectable or metastatic pancreatic adenocarcinoma
- No prior therapy for pancreatic cancer
Adequate organ and marrow function
- Absolute neutrophil count >= 1.5 x 10^9/L
- Platelets >= 100 x 10^9/L
- Total bilirubin <= institutional upper limits of normal
- AST (SGOT)/ALT(SGPT) <= 2 x institutional upper limits of normal
- Serum creatine <= 1.5 x upper limits of normal
- Negative pregnancy test
- Informed consent
- Patient must agree not to smoke while on study
Exclusion Criteria:
- Significant history of cardiac disease unless the disease is well controlled
- Active or uncontrolled infections or serious illness or medical conditions that could interfere with the patient's ongoing participation in study
- History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
- History of smoking within the previous 14 days before enrollment or positive cotinine test at baseline
- Pregnant or breast-feeding females
- Symptomatic brain metastases that are not stable, that require steroids, that are potentially life-threatening, or that have required radiation within the last 14 days
- History of allergic reactions attributed to compounds of similar chemical or biological composition to the study drugs
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010945
Locations
| United States, California | |
| Desert Comprehensive Cancer Center | |
| Palm Springs, California, United States, 92262 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Tennessee | |
| Vanderbilt Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232 | |
Sponsors and Collaborators
OSI Pharmaceuticals
Criterium Inc.
Investigators
| Study Director: | Medical Monitor | Astellas Pharma Global Development |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc ( OSI Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01010945 History of Changes |
| Other Study ID Numbers: | OSI-774-108, 09PAN01 |
| Study First Received: | November 6, 2009 |
| Last Updated: | August 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
Advanced Pancreatic Cancer erlotinib gemcitabine |
nab-paclitaxel Adenocarcinoma Phase 1b |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Erlotinib 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 Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013