CONKO-008: Oxaliplatin/Folinic acid/5-Fluorouracil (24h ) in combination with Lapatinib as a second line therapy in pancreatic cancer after progression under Gemcitabine mono first line therapy- a phase 1/2 trial

Phase 1

Recruiting

• Conditions: C25.7; Endocrine pancreas; Other parts of pancreas; C25.4

• Registration Number: DRKS00000289
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

histologically proven pancreatic adenocarcinoma
- only phase 2: metastasized disease
- Karnofsky performance status >60
- Progression under Gemcitabine
- Time of progression to study enrollment not more than 4 weeks
- measurable disease
- normal cardiac function (ECG, LVEF > 55%)
- Age > 18 and legal capacity
- adequate organ function (bone marrow: neutrophils > 1.5 x109/l, hemoglobin > 10g/dl , platelets> 100x109/l; liver: albumine > 2.5 g/dl, AST/ALT > 3x ULN (>5xULN in case of liver metastasis), renal function: creatinine within normal range or clearance > 60 ml/min according to cockrauft gault

Exclusion Criteria

- preceding radiation
-preceding erlotinib therapy (only phase 2)
- pregnancy/breast feeding
-secondary cancers with exception of basal cell carcinoma of the skin
- cardiac insufficiency NYHA2-4, myocardial infarctation, instable angina pectoris , PTCA or stenting during last 6 months.
-cardiac arrhythmia
- arterial or venous thrombembolic events including stroke, TIA, PRIND, cns bleeding during last 6 months
- known malabsorption including Crohn disease or ulcerous colitis or preceding surgery which may affect uptake of the substance
- severe concomitant diseases which could affect study participation according to the investigator
- participant not willing to take adequate contraception
- pregnancy
- known allergies to the used substances
- lack of compliance
- need of parallel other tumor therapy like biological, hormonal, immunological, radiation- or chemotherapy
- patients ordered to be hospitalized by legal decision
- therapy with a not approved substance during the last 4 weeks need for a concomitant therapy with a substance which could influence metabolism of the test substance

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of Lapatinib in combination with the given chemotherapy.

Secondary Outcome Measures

Name	Time	Method
Tolerability and toxicity.