Oxaliplatin/folinic acid/5-fluorouracil (24-hour) (OFF) plus best supportive care versus best supportive care alone (BSC) in second-line therapy of gemcitabine-refractory advanced pancreatic cancer

Phase 3

Completed

• Conditions: Pancreatic cancer; Cancer

• Registration Number: ISRCTN52780546
• Lead Sponsor: Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Brief Summary

2005 results in http://dx.doi.org/10.1200/jco.2005.23.16_suppl.4031 (added 08/04/2021) 2014 results in https://pubmed.ncbi.nlm.nih.gov/24982456/ (added 08/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-12-31
• Study Start: 2007-12-21
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Histologically or cytologically proven advanced pancreatic cancer after confirmed failure of treatment with gemcitabine
2. No more than three weeks between confirmed failure of treatment with gemcitabine and start of second-line therapy
3. Karnofsky performance status greater than 70%
4. Measurable disease of more than 15 x 15 mm per computed tomography (CT) or magnetic resonance (MR) scan
5. Leucocytes greater than 3.5 x 10^9/L, platelets greater than 100 x 10^9/L
6. Written informed consent
7. Age of 18 years or more
8. Sufficient contraception up to three months after the end of therapy

Exclusion Criteria

1. Active infection (as decided by physician)
2. Pregnant or breastfeeding women
3. Psychiatric disorders
4. Heavy disorders, contradictory with study (as decided by physician)
5. Heavy complications of the tumour, requiring an acute therapy
6. Heavy cardiac disorders
7. Peripheral, sensory and/or motor neuropathy (greater than II° - grade of sensoric/motoric toxicity regarding National Cancer Institute [NCI] criteria)
8. Hyperesthesia against study medication or related drugs
9. Patients with renal failure (creatinine clearance less than 30 ml/min)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival, progression free survival: Kaplan Meyer Plot (current version of SPSS).

Secondary Outcome Measures

Name	Time	Method
<br> 1. Rate of remission: description with tabulations, as percentage of the two treatment groups, duration of remission<br> 2. Toxicity: NCI Common Toxicity Criteria (CTC) grade differentation, description with tabulations<br> 3. Quality of life: tabulation descriptions, assesment with box-plot (current version of SPSS)<br>