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

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

gemcitabine hydrochloride

sorafenib tosylate

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas, recurrent pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Inclusion criteria:

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

Exclusion criteria:

Brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

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

Exclusion criteria:

Pregnant or nursing
Intestinal occlusion
Prior inflammatory intestinal disease
Crohn's disease
Hemorrhagic rectal colitis
Peripheral neuropathy > grade 2
Other severe illness, including any of the following:
- Unstable cardiac disease, even if treated
- Psychological or neurological disease including dementia
- Uncontrolled active infection
- Other severe illness that would compromise study participation
Impossible to receive study therapy due to geographical, social, or psychological reasons
Other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

See Disease Characteristics
At least 6 months since prior chemotherapy or radiochemotherapy
At least 4 weeks since prior radiotherapy and/or surgery

Exclusion criteria:

Prior therapy for advanced disease
Prior inhibitors of kinase signaling (e.g., ras/raf, MEK, AKT, mTOR, or farnesyl transferase)
Prior inhibitors of angiogenesis (e.g., bevacizumab)
Prior organ graft or allogeneic transplantation
Prior extensive intestinal resection
Concurrent participation in another therapeutic study
Concurrent inductors of CYP3A4 (e.g., barbiturates, anti-epileptics, or rifampicin)

Sites / Locations

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

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Toxicities

Response rate

Overall survival

Clinical benefits

Quality of life by QLQ-C30

Biomarkers of response

Full Information

NCT ID

NCT00541021

First Posted

October 5, 2007

Last Updated

December 13, 2009

Sponsor

Institut Paoli-Calmettes

1. Study Identification

Unique Protocol Identification Number

NCT00541021

Brief Title

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

Official Title

Phase III Randomized, Double-blind Study Comparing Gemcitabine and Sorafenib or a Placebo in Patients With Locally Advanced or Metastatic Cancer of the Pancreas.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

December 2006 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Institut Paoli-Calmettes

4. Oversight

5. Study Description

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.

Detailed Description

OBJECTIVES: Primary Compare progression-free survival. Secondary Compare toxicities. Compare response rate. Compare overall survival. Evaluate clinical benefits. Compare quality of life. Identify biomarkers that predict therapeutic response. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral sorafenib tosylate twice daily and gemcitabine hydrochloride IV once weekly for 7 weeks followed by 1 week of rest (course1). For the next 2 courses, patients receive gemcitabine hydrochloride weekly for 3 weeks followed by 1 week of rest and sorafenib tosylate twice daily. Arm II: Patients receive oral placebo twice daily and gemcitabine hydrochloride as in arm I. After completing 3 courses of therapy, patients in both arms who have stable or responding disease may continue to receive sorafenib tosylate or placebo in the absence of disease progression or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Masking

Double

Allocation

Randomized

Enrollment

104 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Intervention Type

Drug

Intervention Name(s)

sorafenib tosylate

Primary Outcome Measure Information:

Title

Progression-free survival

Secondary Outcome Measure Information:

Title

Toxicities

Title

Response rate

Title

Overall survival

Title

Clinical benefits

Title

Quality of life by QLQ-C30

Title

Biomarkers of response

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Inclusion criteria: Diagnosis of adenocarcinoma of the pancreas Locally advanced or metastatic disease Measurable disease, defined as at least 1 lesion measurable by RECIST criteria Exclusion criteria: Brain metastases PATIENT CHARACTERISTICS: Inclusion criteria: 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 Exclusion criteria: Pregnant or nursing Intestinal occlusion Prior inflammatory intestinal disease Crohn's disease Hemorrhagic rectal colitis Peripheral neuropathy > grade 2 Other severe illness, including any of the following: Unstable cardiac disease, even if treated Psychological or neurological disease including dementia Uncontrolled active infection Other severe illness that would compromise study participation Impossible to receive study therapy due to geographical, social, or psychological reasons Other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Inclusion criteria: See Disease Characteristics At least 6 months since prior chemotherapy or radiochemotherapy At least 4 weeks since prior radiotherapy and/or surgery Exclusion criteria: Prior therapy for advanced disease Prior inhibitors of kinase signaling (e.g., ras/raf, MEK, AKT, mTOR, or farnesyl transferase) Prior inhibitors of angiogenesis (e.g., bevacizumab) Prior organ graft or allogeneic transplantation Prior extensive intestinal resection Concurrent participation in another therapeutic study Concurrent inductors of CYP3A4 (e.g., barbiturates, anti-epileptics, or rifampicin)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederic Viret, MD

Organizational Affiliation

Institut Paoli-Calmettes

Facility Information:

Facility Name

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

City

Marseille

ZIP/Postal Code

13273

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frederic Viret, MD

Phone

33-4-91-22-35-37

viretf@marseille.fnclcc.fr

12. IPD Sharing Statement

Learn more about this trial

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

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