Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Frederic Viret, MD

Investigator Affiliation:

Institut Paoli-Calmettes

Authority:

Unspecified

Study ID:

CDR0000564099

NCT ID:

NCT00541021

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • adenocarcinoma of the pancreas
  • recurrent pancreatic cancer
  • Pancreatic Neoplasms

Name

Location