Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer
Adenocarcinoma of the Gastroesophageal Junction
Metastatic Gastric Cancer
Advanced Unresectable Gastric Cancer
Drug: BAY 43-9006
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study to Evaluate Overall Response Rate of BAY 43-9006 (Sorafenib) Combined With Docetaxel and Cisplatin or Oxaliplatin in the Treatment of Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma|
- The Proportion of Patients With Objective Response (Complete Response or Partial Response) [ Time Frame: Assessed every 6 weeks until disease progression or up to 3 years ] [ Designated as safety issue: No ]Response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.
- Progression-free Survival (PFS) [ Time Frame: Assessed every 6 weeks until disease progression or up to 3 years ] [ Designated as safety issue: No ]
Progression-free survival was defined as the shorter of:
- The time from registration to progression. or
- The time from registration to death without documentation of progression given that the death occurs within 4 months of the last disease assessment without progression (or registration, whichever is more recent).
Therefore, cases not meeting either of the criteria for a PFS event are censored at the date of last disease assessment without progression (or registration, whichever is more recent).
Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions.
- Overall Survival (OS) [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry; then every 6 months if patient is 2-3 years from study entry. ] [ Designated as safety issue: No ]Overall survival was defined as the time from registration to death from any cause.
|Study Start Date:||October 2005|
|Study Completion Date:||September 2010|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Experimental: BAY 43-9006, docetaxel, cisplatin
Patients receive oral BAY 43-9006 400mg twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: BAY 43-9006
Other Names:Drug: docetaxel
Other Names:Drug: cisplatin
I. To evaluate the response rate (complete response and partial response) of the combination of BAY 43-9006 with docetaxel and cisplatin or oxaliplatin in patients with gastric and GEJ adenocarcinoma.
II. To evaluate the progression-free survival (PFS) and overall survival.
III. To evaluate the toxicities of BAY 43-9006 in patients with advanced and metastatic gastric or GEJ adenocarcinoma combined with docetaxel/cisplatin or docetaxel/oxaliplatin.
IV. To evaluate Raf status in the tumor and to correlate response and PFS to the presence or absence of an activating mutation in B-Raf.
V. To analyze the pharmacokinetic and pharmacogenetic properties of BAY 43-9006 including angiogenesis, monooxygenases, polymorphisms and multidrug-resistance (MDR). This study will be conducted via the E1Y03 mechanism.
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 BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel intravenously (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.
An addition of an arm containing oxaliplatin was proposed after meeting the accrual goal but did not move forward and the study was closed to accrual in July, 2007 with a final accrual of 44 patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253370
|United States, Massachusetts|
|Eastern Cooperative Oncology Group|
|Boston, Massachusetts, United States, 02215|
|Study Chair:||Weijing Sun, MD||University of Pennsylvania|