Larotaxel Compared To Continuous Administration of 5-FU in Advanced Pancreatic Cancer Patients Previously Treated With A Gemcitabine-Containing Regimen (PAPRIKA)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Pancreatic Neoplasms

Treatments: Drug: Larotaxel (XRP9881); Drug: 5-Fluorouracil; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00417209

EFC6596

EUDRACT: 2006-003086-14

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and the safety Larotaxel administered as single agent every 3 weeks to continuous administration of 5-FU every 3 weeks, in patients with advanced pancreatic cancer (non operable in a curative intent, locally recurrent or metastatic) previously treated with gemcitabine based therapy.

Enrollment: 408 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced (non operable in a curative intent, locally recurrent or metastatic disease) Cytologically or histologically proven epithelial cancer (adenocarcinoma) of the exocrine pancreas.
• Patient must be previously treated with a systemic gemcitabine based regimen
• Adequate bone marrow, kidney and liver functions

Exclusion criteria

• ECOG performance status (PS) of 2-3-4.
• Prior locoregional radiotherapy for pancreatic cancer.
• Symptomatic brain metastases or leptomeningeal disease.
• Any serious intercurrent infections, uncontrolled cardiac or gastro-intestinal diseases.
• Other concurrent malignancy
• Other protocol-defined exclusion/inclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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408 participants in 2 patient groups

Larotaxel (XRP9881)

Experimental group

Treatment:

Drug: Larotaxel (XRP9881)

5-Fluorouracil or capecitabine

Active Comparator group

Description:

Each Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site.

Treatment:

Drug: 5-Fluorouracil

Drug: Capecitabine