Gemcitabine Plus Erlotinib in RASH-positive Patients With Metastatic Pancreatic Cancer

NCT01729481 | Unknown Phase 2 DMC

• 1 other identifier: 2011-005471-17
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 1-year Survial rate of "good-risk" patients

  1-year Survial rate of "good-risk" patients of patients under gemcitabine plus erlotinib with RASH

  Follow-Up Phase (1.5 years)

Secondary Outcomes (3)

• Evalutation of overall response rate, disease control rate and progression free survival

  Approximately 12 months

• Evaluation of adverse events

  Treatment Phase (1.5 Years)

• Translational Projects

  Approximately 24 months

Study Arms (2)

RASH positive

EXPERIMENTAL

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.

Drug: Gemcitabine; Drug: Erlotinib

RASH-negative

ACTIVE COMPARATOR

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

Drug: Oxaliplatin; Drug: Folinic Acid; Drug: Irinotecan; Drug: 5-FU

Interventions

Gemcitabine DRUG

1000 mg/m² iv weekly

Also known as: Gemzar

RASH positive

Erlotinib DRUG

100mg, once per day

Also known as: Tarceva

RASH positive

Oxaliplatin DRUG

85mg/m², q2weeks

Also known as: Eloxatin

RASH-negative

Folinic Acid DRUG

400 mg/m², q2weeks

Also known as: Leucovorin

RASH-negative

Irinotecan DRUG

180 mg/m², q2weeks

Also known as: Campto

RASH-negative

5-FU DRUG

400 mg/m² Day 1; 2400 mg/m² 46 hour invusion, q2weeks

Also known as: 5-Flourouracil

RASH-negative

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Roche Pharma AG: collaborator

Study Sites (1)

University of Munich

Munich, 81377, Germany

Location

Related Publications (2)

• Weiss 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 DERIVED

• Haas 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 DERIVED

Related Links

• Homepage of the PancreasCenter at LMU Munich

MeSH Terms

Interventions

Gemcitabine; Erlotinib Hydrochloride; Oxaliplatin; Leucovorin; Irinotecan; Fluorouracil

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids; Uracil; Pyrimidinones

Study Officials

• Volker Heinemann, Professor

  Medical Department III and Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: November 20, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

DE (1)