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Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Locally Advanced Gastric or Gastroesophageal Junction Cancer That Cannot be Removed By Surgery
This study has been suspended.
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00253370
  Purpose

RATIONALE: 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. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with docetaxel and cisplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sorafenib together with docetaxel and cisplatin works in treating patients with metastatic or locally advanced gastric or gastroesophageal junction cancer that cannot be removed by surgery.


Condition Intervention Phase
Gastric Cancer
Drug: cisplatin
Drug: docetaxel
Drug: sorafenib tosylate
Phase II

MedlinePlus related topics: Cancer Stomach Cancer
Drug Information available for: Docetaxel Cisplatin Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study to Evaluate Overall Response Rate of BAY 43-9006 (Sorafenib) Combined With Docetaxel And Cisplatin in the Treatment of Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate (partial and complete response) [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Designated as safety issue: No ]
  • Safety and toxic effects [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Designated as safety issue: No ]
  • Pharmacogenetics [ Designated as safety issue: No ]
  • Correlation of Raf status in the tumor with response and PFS [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: October 2005
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the overall response rate (partial and complete response) in patients with metastatic or locally advanced unresectable gastric or gastroesophageal junction adenocarcinoma treated with sorafenib, docetaxel, and cisplatin.
  • Determine the overall and progression-free survival (PFS) of patients treated with this regimen.
  • Determine the safety and toxic effects of this regimen in these patients.
  • Determine the pharmacokinetics and pharmacogenetics of this regimen in these patients.
  • Correlate Raf status in the tumor with response and PFS of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to Siewert's tumor location (I vs II vs III) and extent of disease (locally advanced unresectable vs distant metastases).

Patients receive oral sorafenib twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma

    • Metastatic or locally advanced unresectable disease
    • Siewert's class I, II, or III disease for patients with GEJ adenocarcinoma
  • Measurable disease
  • No known brain metastases

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 3,000/mm^3
  • No evidence of bleeding diathesis

Hepatic

  • Bilirubin ≤ 2 mg/dL
  • AST and ALT ≤ 2.5 times the upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 mg/dL

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled hypertension

Immunologic

  • No history of allergic reaction to compounds of similar chemical or biologic composition to sorafenib
  • No acute active infection requiring significant clinical intervention

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be able to take oral medication without crushing, dissolving, or chewing tablets
  • No other uncontrolled illness
  • No psychiatric illness or addictive disorder that would preclude study compliance
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior antiangiogenesis therapy for recurrent or metastatic disease

Chemotherapy

  • Prior adjuvant chemotherapy or chemoradiotherapy allowed (with or without fluorouracil) if completed more than 6 months before evidence of recurrent or metastatic disease
  • No prior chemotherapy for recurrent or metastatic disease

Radiotherapy

  • See Chemotherapy
  • No prior radiotherapy for recurrent or metastatic disease

Surgery

  • Not specified

Other

  • No prior tyrosine kinase inhibitor therapy or signal transduction inhibitor therapy for recurrent or metastatic disease
  • No prior investigational agents for recurrent or metastatic disease
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs including the following:

    • Phenytoin
    • Carbamazepine
    • Phenobarbital
    • Rifampin
    • Hypericum perforatum (St. John's wort)
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253370

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Weijing Sun, MD University of Pennsylvania
Investigator: Peter J. O'Dwyer, MD, BCh University of Pennsylvania
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Sun W, Powell ME, O'Dwyer P, et al.: A phase II study: combination of sorafenib with docetaxel and cisplatin in the treatment of metastatic or advanced unresectable gastric and gastroesophageal junction (GEJ) adenocarcinoma (ECOG 5203). [Abstract] J Clin Oncol 26 (Suppl 15): A-4535, 2008.

Study ID Numbers: CDR0000450764, ECOG-E5203
Study First Received: November 11, 2005
Last Updated: October 23, 2008
ClinicalTrials.gov Identifier: NCT00253370  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent gastric cancer
stage IV gastric cancer
stage III gastric cancer
adenocarcinoma of the stomach

Study placed in the following topic categories:
Docetaxel
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Cisplatin
Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Adenocarcinoma
Sorafenib
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009