Cetuximab and Trastuzumab in Treating Patients With Metastatic Pancreatic Cancer That Progressed After Previous Treatment With Gemcitabine
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Centre Val d'Aurelle - Paul Lamarque
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00923299
First received: June 17, 2009
Last updated: June 20, 2009
Last verified: June 2009
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Purpose
RATIONALE: Monoclonal antibodies, such as cetuximab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving cetuximab together with trastuzumab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of trastuzumab when given together with cetuximab and to see how well it works in treating patients with metastatic pancreatic cancer that progressed after previous treatment with gemcitabine.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Biological: cetuximab Biological: trastuzumab |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I-II Study Evaluating Combined Treatment of Cetuximab and Trastuzumab in Metastatic Pancreatic Cancer Patients Progressing After Gemcitabine Based Chemotherapy. |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Recommended dose of trastuzumab when given with cetuximab (Phase I) [ Designated as safety issue: No ]
- Objective response rate as assessed by RECIST criteria (Phase II) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 67 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the recommended dose of trastuzumab when given with cetuximab in patients with metastatic pancreatic cancer that progressed after gemcitabine-based chemotherapy. (Phase I)
- Evaluate the objective response rate as assessed by RECIST criteria. (Phase II)
Secondary
- Evaluate the safety profile as assessed by NCI CTCAE v3.0.
- Evaluate progression-free survival.
- Evaluate overall survival.
OUTLINE: This is a multicenter, phase I dose-escalation study of trastuzumab followed by a phase II study.
Patients receive cetuximab IV over 1-2 hours and trastuzumab IV over 30-90 minutes on day 1. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic adenocarcinoma of the pancreas
- Progressed after first-line or adjuvant gemcitabine-based chemotherapy
- Measurable disease as assessed by RECIST criteria
- No known brain metastasis or symptomatic carcinomatous leptomeningitis
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 2.5 times ULN
- ALT/AST ≤ 5 times ULN
- LVEF ≥ 55%
- Not pregnant or nursing
- Fertile patients must use effective contraception
No significant comorbidities, including any of the following:
- Cardiovascular disease
- Documented history of congestive heart failure
- Uncontrolled, high-risk arrhythmia
- Angina pectoris requiring treatment
- Clinically significant valvular disease
- Evidence of transmural myocardial infarction by ECG
- Uncontrolled hypertension
- Active bleeding
- Clinically significant active infection
- Severe dyspnea at rest
- Oxygen-dependency
- No other malignancy except basal cell carcinoma of the skin
- No severe hypersensitivity to cetuximab or trastuzumab
- No medical or psychological condition that would preclude study completion or giving informed consent
- No legal incapacity or limited legal capacity
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior cetuximab or trastuzumab
- No other concurrent experimental drugs or anticancer therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923299
Locations
| France | |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Recruiting |
| Montpellier, France, 34298 | |
| Contact: Marc Ychou, MD, PhD 33-4-6761-3066 mychou@valdorel.fnclcc.fr | |
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Investigators
| Principal Investigator: | Marc Ychou, MD, PhD | Centre Val d'Aurelle - Paul Lamarque |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00923299 History of Changes |
| Other Study ID Numbers: | CDR0000636018, CLCC-THERAPY, RECF0910, VA-2008/34, EUDRACT-2008-003988-39 |
| Study First Received: | June 17, 2009 |
| Last Updated: | June 20, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IV pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas |
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 Trastuzumab Cetuximab 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 |
ClinicalTrials.gov processed this record on May 21, 2013