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

• Register: ISRCTN
• Last refreshed on: 19 April 2021
• Main ID: ISRCTN52780546
• Date of registration: 21/12/2007
• Prospective Registration: No
• Primary sponsor: Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 01/01/2004
• Target sample size: 165
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN52780546
• Study type: Interventional
• Study design: Prospective, open, multicentre, randomised, controlled phase III trial (Treatment)
• Phase: Phase III

Countries of recruitment

Germany

Contacts

• Name: Helmut Oettle

Key inclusion & exclusion criteria

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)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Pancreatic cancer
Cancer
Pancreatic cancer

Intervention(s)

After stratification for duration of first line therapy, Karnofsky Performance Status (KPS) and tumour stage, patients were randomised and treated with 5-fluorouracil (FU) 2 g/m^2 (24-hour)/folinic acid (FA) 200 mg/m^2 (FF) on days 1, 8, 15 and 22 with or without oxaliplatin 85 mg/m^2 (2-hour) on days 8 and 22. Therapy paused on days 23 to 42.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

German Tumour Study Registry (Deutsches KrebsStudienRegister) ID No.: 427; CONKO-003

NCT00786058

Source(s) of Monetary Support

Amgen GmbH (Germany), Medac (Germany), Ribosepharm GmbH (Germany), Sanofi-Aventis Deutschland GmbH (Germany)

Results

• Results available: Yes
• Date Completed: 31/12/2006