A Randomized, Open Label Multi-Center Study of Single Agent Larotaxel (XRP9881) Compared to Continuous Administration of 5-FU For The Treatment of Patients With Advanced Pancreatic Cancer Previously Treated With A Gemcitabine-Containing Regimen - PAPRIKA

• Conditions: Advanced Pancreatic Cancer.; MedDRA version: 11.1Level: LLTClassification code 10033604Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2006-003086-14-CZ
• Lead Sponsor: sanofi-aventis recherche & developpement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 434

Inclusion Criteria

1. Cytologically or histologically confirmed evidence of epithelial cancer (adenocarcinoma) of the exocrine pancreas.

2. Advanced disease defined as non operable in a curative intent, locally advanced or metastatic disease. Patients with nonmeasurable disease (as per RECIST criteria) are eligible.

3. Patient must be previously treated with a systemic gemcitabine based regimen given as adjuvant chemotherapy (disease free interval must be less than 6 months) or as therapy for advanced disease.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Disease localized only to the radiation fields without radiologically confirmed progression of the disease within the radiation fields after completion of prior radiotherapy.

Prior therapy:
- More than one previous chemotherapy regimen for advanced pancreatic disease.
- Prior locoregional radiotherapy for pancreatic cancer.
- Less than 4 weeks elapsed from prior chemotherapy (except for weekly regimen for which 3 weeks are allowed) or radiotherapy, less than 3 weeks from surgery and less than 10 days from last prior administration of erlotinib, to the time of randomization.

General conditions:
- Age < 18 years.
- ECOG performance status (PS) of 2-3-4.
- Patient with organ functions as follows: ANC < 2,000/mm3, platelets < 100,000/mm3, hemoglobin < 10 g/dL, total bilirubin > ULN, SGOT/SGPT > 1.5 x ULN if AP = 5 and > 2.5 x ULN or SGOT/SGPT > 2.5 x ULN if AP = 2.5 x UNL, AP > 5 x ULN, Serum creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, a creatinine clearance calculated according to Cockcroft-Gault formula < 60 mL/min will exclude the patient.

• Prior or current history:
History of another neoplasm. Patients with prior history of either non-melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery, small field radiation or chemotherapy > 5 years prior to randomization, will be eligible.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether single agent larotaxel increases overall survival when compared to continuous administration of 5-Fluorouracil (5-FU) in patients with advanced pancreatic cancer previously treated with a gemcitabine-based therapy;Primary end point(s): Overall survival.;Secondary Objective: *To compare on the two treatment arms:·<br>-Progression Free Survival (PFS),<br>-Overall Response Rate (ORR), <br>-Clinical Benefit assessed by Time to symptoms worsening (TTSW) and improvement in tumor related symptoms,<br><br>*To assess the overall safety of the two arms,<br><br>*To assess the pharmacokinetics of larotaxel in this patient population (sample size of 50 larotaxel-treated patients for sparse sampling).