Gemcitabine With or Without Sorafenib in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

NCT00541021 | Unknown Phase 3

• 4 other identifiers: CDR0000564099IPC-BAYPANINCA-RECF0426IPC-2005-006
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether giving gemcitabine together with sorafenib is more effective than giving gemcitabine alone in treating pancreatic cancer. PURPOSE: This randomized phase III trial is studying giving gemcitabine together with sorafenib to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

stage III pancreatic cancer; stage IV pancreatic cancer; adenocarcinoma of the pancreas; recurrent pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (6)

• Toxicities

• Response rate

• Overall survival

• Clinical benefits

• Quality of life by QLQ-C30

Interventions

gemcitabine hydrochloride DRUG

sorafenib tosylate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of adenocarcinoma of the pancreas
• Locally advanced or metastatic disease
• Measurable disease, defined as at least 1 lesion measurable by RECIST criteria

You may not qualify if:

• Brain metastases
• PATIENT CHARACTERISTICS:
• WHO performance status 0-2
• Absolute neutrophil count \> 1,500/mm\^3
• Platelet count \> 100,000/mm\^3
• Creatinine \< 1.5 times normal
• Transaminases \< 2 times normal (5 times normal if liver metastases)
• Total bilirubin \< 1.5 times normal
• Fertile patients must use effective contraception
• Pregnant or nursing
• Intestinal occlusion
• Prior inflammatory intestinal disease
• Crohn's disease
• Hemorrhagic rectal colitis
• Peripheral neuropathy \> grade 2

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Sorafenib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Study Officials

• Frederic Viret, MD

  Institut Paoli-Calmettes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: December 1, 2006
• Primary Completion: December 1, 2010
• Last Updated: December 15, 2009

Record last verified: 2009-07

Locations

FR (1)