Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Centre Antoine Lacassagne
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00885066
First received: April 18, 2009
Last updated: December 23, 2009
Last verified: July 2009
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Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Cancer |
Drug: capecitabine Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers |
Resource links provided by NLM:
Drug Information available for:
Gemcitabine
Gemcitabine hydrochloride
Capecitabine
Erlotinib hydrochloride
Erlotinib
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Clinical or laboratory toxicities as assessed by CTC [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.
Secondary
- Analyze the limiting toxicities according to CTC.
- Analyze the toxicity according to CTC.
- Determine the recommended dose.
- Determine the pharmacokinetic dosages of the three drugs.
- Analyze interactions between the drugs.
OUTLINE: This is a multicenter study.
Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Advanced disease
- No standard curative therapy available
- Must have received prior first-line chemotherapy
- No brain metastasis
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 8 weeks
- ANC ≥ 1.5 x 10^9/ L
- Platelet count ≥ 130 x 10^9/ L
- Hemoglobin ≥ 10 g/dL
- Liver transaminases ≤ 1.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 130 mmol/L OR creatinine clearance > 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No intolerance or hypersensitivity to any of the drugs being tested
- No history of interstitial lung disease
- No history of severe cardiac disease
- No serious uncontrolled infection
- No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome
- Must not be deprived of liberty or under guardianship
- Must not be on probation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior erlotinib hydrochloride
- No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4
- More than 14 days since participation in another clinical trial
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885066
Locations
| France | |
| Centre Antoine Lacassagne | Recruiting |
| Nice, France, 06189 | |
| Contact: Eric Francois 33-04-9203-1114 | |
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
| Principal Investigator: | Eric Francois | Centre Antoine Lacassagne |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00885066 History of Changes |
| Other Study ID Numbers: | CDR0000633338, CALACASS-CAPERGEM, ROCHE-CALACASS-CAPERGEM, INCA-RECF0622, EUDRACT-2007-005072-14 |
| Study First Received: | April 18, 2009 |
| Last Updated: | December 23, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage III pancreatic cancer stage IV pancreatic cancer adenocarcinoma of the pancreas recurrent pancreatic cancer |
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 Capecitabine Fluorouracil 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 |
ClinicalTrials.gov processed this record on May 19, 2013