Clinical trial · Interventional
Gemcitabine Plus Erlotinib in RASH-positive Patients With Metastatic Pancreatic Cancer
Phase II Study to Evaluatate the Efficacy of Gemcitabine Plus Erlotinib for RASH-positive Patients With Metastatic Pancreatic Cancer and Friendly Risk Circumstances
NCT01729481CI-TRIAL-00028693ML22774unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
In the current study it is examined whether patients with good risk factors (age \<75 years, total serum bilirubin \< 1,5xULN, no history of cardiovascular diseases) treated with gemcitabine and erlotinib who developed skin rash of any grade during the first 4 weeks of treatment have a comparable outcome as patients who receive FOLFIRINOX.
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 |
|---|---|---|---|
| Metastatic Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Erlotinib | Drug | Erlotinib | ALIAS |
| Folinic Acid | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RASH positive
- description
- Run-In-Phase during 4 weeks: Gemcitabine 1000 mg/m², weekly Erlotinib 100 mg, weekly Thereafter Treatment in patients with RASH-positve outcome after 4 weeks.
- interventionNames
- Drug: Gemcitabine
- Drug: Erlotinib
- type
- ACTIVE_COMPARATOR
- label
- RASH-negative
- description
- Run-In-Phase during 4 weeks: Gemcitabine 1000 mg/m², weekly Erlotinib 100 mg, weekly RASH-negative patients quit treatment with Gemcitabine + Erlotinib and continue treatment with FOLFIRINOX: Oxaliplatin 85mg/m2 Irinotecan 180 mg/m2 Folinic acid 400 mg/m2 5-FU 400 mg/m2 bolus iv 5-FU 2400 mg/m2 46-hours continous infusion
- interventionNames
- Drug: Oxaliplatin
- Drug: Folinic Acid
- Drug: Irinotecan
- Drug: 5-FU
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically (not cytologically) confirmed metastatic pancreatic adenocarcinoma (stage IV according to UICC, each T, each N, M1 according to TNM) * At least one measurable index lesion (CT or MRI) according to RECIST criteria (V 1.1) * ECOG PS 0 and 1 * Age 18-75 years * Serum bilirubin ≤1,5x ULN (a placed biliary tract stent without concurrent cholangitis is not considered a contraindication) * Availability of tumour samples (no cytologic samples) * Written informed consent by the patient for collecting blood- and tumour-samples for translational research according to study protocol * Live expectancy of at least three months * Written informed consent * Negative pregnancy test in women with childbearing potential (to be performed within 7 days prior to treatment start) * Adequate kidney-, liver- and bone-marrow function: neutrophils \>= 1500/µl, platelets \>= 100.000/µ, and hemoglobin \>= 8g/dl, liver transaminases\<= 2,5x ULN, in case of liver metastases \<= 5x ULN, serum creatinine \<= 1,25x ULN, creatinine clearance ≥ 30 ml/min * Legal capacity of the patient * Option for constant long-term follow-up Exclusion Criteria: * Resectable pancreatic carcinoma * Locally advanced pancreatic cancer (non-resectable tumour without distant metastasis) * Previous palliative chemotherapy for metastatic or locally advanced, non-resectable pancreatic cancer * Previous palliative radiation or chemoradiation for locally advanced, non-resectable pancreatic cancer * Radiation therapy within four weeks prior to study enrolment or radiation of indicator lesions * Adjuvant Chemotherapy or Radiochemotherapy for pancreatic cancer ≤ 6 months prior to study ernrolment * All previously occurred metastatic cancers or cured neoplasias diagnosed within the last 5 years before study enrolment * Major surgery within 2 weeks before study start * Chronic diarrhea * Known glucuronidation-deficiency (Gilbert´s syndrome) * Acute or subacute ileus or chronic inflammatory bowel disease * Preexisting polyneuropathy \> Grade I according to NCI-CTCAE v.4.0 * Relevant comorbidities which might impair patient eligibility or safety for study participation like active infections, hepatic, renal or metabolic diseases * Clinically significant cardiovascular diseases within 12 months prior to study start (e.g. unstable angina pectoris, myocardial infarction, heart failure ≥ NYHA II, cardiac arrhythmias requiring treatment)
References
Publications (2)
- DERIVEDWeiss L, Heinemann V, Fischer LE, Gieseler F, Hoehler T, Mayerle J, Quietzsch D, Reinacher-Schick A, Schenk M, Seipelt G, Siveke JT, Stahl M, Vehling-Kaiser U, Waldschmidt DT, Dorman K, Zhang D, Westphalen CB, von Bergwelt-Baildon M, Boeck S, Haas M. Three-month life expectancy as inclusion criterion for clinical trials in advanced pancreatic cancer: is it really a valid tool for patient selection? Clin Transl Oncol. 2024 May;26(5):1268-1272. doi: 10.1007/s12094-023-03323-1. Epub 2023 Oct 4. PMID 37794220
- DERIVEDHaas M, Siveke JT, Schenk M, Lerch MM, Caca K, Freiberg-Richter J, Fischer von Weikersthal L, Kullmann F, Reinacher-Schick A, Fuchs M, Kanzler S, Kunzmann V, Ettrich TJ, Kruger S, Westphalen CB, Held S, Heinemann V, Boeck S. Efficacy of gemcitabine plus erlotinib in rash-positive patients with metastatic pancreatic cancer selected according to eligibility for FOLFIRINOX: A prospective phase II study of the 'Arbeitsgemeinschaft Internistische Onkologie'. Eur J Cancer. 2018 May;94:95-103. doi: 10.1016/j.ejca.2018.02.008. Epub 2018 Mar 20. PMID 29549862