Clinical trial · Interventional
Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gemcitabine, capecitabine, erlotinib
- interventionNames
- Drug: capecitabine
- Drug: erlotinib hydrochloride
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Clinical or laboratory toxicities as assessed by CTC
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTFrancois 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