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Docetaxel

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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.

BAY 43-9006

docetaxel

cisplatin

Weijing Sun, MD

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. 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.

PRIMARY OBJECTIVES:

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.

Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer

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

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 was defined as the shorter of:

1. The time from registration to progression. or
2. 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 was defined as the time from registration to death from any cause.

National Cancer Institute (NCI)

Patients receive oral BAY 43-9006 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.

BAY 43-9006: Given orally

docetaxel: Given IV

cisplatin: Given IV

BAY 43-9006, Docetaxel, Cisplatin

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

All 44 patients started treatment and were considered eligible and hence were included in the analysis.

Study Statistician

The study was designed to distinguish a response rate of 40% from 20%, the null hypothesis. With the planned sample size of 36 eligible patients, the study has 91% power based on a 0.09 level one-sided test.

Patients receive oral BAY 43-9006 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.

BAY 43-9006: Given orally

docetaxel: Given IV

cisplatin: Given IV

All enrolled patients started treatment and were considered eligible and hence were all included in the analysis.

The Proportion of Patients With Objective Response (Complete Response or Partial Response)

Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2over 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.

BAY 43-9006: Given orally

docetaxel: Given IV

cisplatin: Given IV

Progression-free Survival (PFS)

Overall Survival (OS)

Patients receive oral BAY 43-9006 400 mg twice daily on days 1-21. Patients also receive docetaxel IV, 75mg/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.

BAY 43-9006: Given orally

docetaxel: Given IV

cisplatin: Given IV

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer	NCT00253370	Adenocarcinoma ... Metastatic Gast... Advanced Unrese...	BAY 43-9006 docetaxel cisplatin	18 Years -	National Cancer Institute (NCI)
Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer	NCT00253370	Adenocarcinoma ... Metastatic Gast... Advanced Unrese...	BAY 43-9006 docetaxel cisplatin	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for advanced unresectable gastric cancer