Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer

NCT00885066 | Completed Phase 1

• 5 other identifiers: 2007/36CALACASS-CAPERGEMROCHE-CALACASS-CAPERGEMINCA-RECF06222007-005072-14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancer; stage IV pancreatic cancer; adenocarcinoma of the pancreas; recurrent pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Clinical or laboratory toxicities as assessed by CTC

  1 year

Study Arms (1)

gemcitabine, capecitabine, erlotinib

EXPERIMENTAL

Drug: capecitabine; Drug: erlotinib hydrochloride; Drug: gemcitabine hydrochloride

Interventions

capecitabine DRUG

gemcitabine, capecitabine, erlotinib

erlotinib hydrochloride DRUG

gemcitabine, capecitabine, erlotinib

gemcitabine hydrochloride DRUG

gemcitabine, capecitabine, erlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Related Publications (1)

• Francois E, Bennouna J, Chamorey E, Etienne-Grimaldi MC, Renee N, Senellart H, Michel C, Follana P, Mari V, Douillard JY, Milano G. Phase I trial of gemcitabine combined with capecitabine and erlotinib in advanced pancreatic cancer: a clinical and pharmacological study. Chemotherapy. 2012;58(5):371-80. doi: 10.1159/000343969. Epub 2012 Dec 11.

  PMID: 23235319 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Erlotinib Hydrochloride; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Eric Francois

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2009
• First Posted: April 21, 2009
• Study Start: May 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (1)