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

NCT00253370 | Completed Phase 2 Results

• 3 other identifiers: NCI-2012-02951E5203U10CA021115
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenocarcinoma of the Gastroesophageal Junction; Metastatic Gastric Cancer; Advanced Unresectable Gastric Cancer

Keywords

Sorafenib; Docetaxel; Cisplatin; gastric cancer; gastroesophageal junction adenocarcinoma

Outcome Measures

Primary Outcomes (1)

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

  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.

  Assessed every 6 weeks until disease progression or up to 3 years

Secondary Outcomes (2)

• Progression-free Survival (PFS)

  Assessed every 6 weeks until disease progression or up to 3 years

• Overall Survival (OS)

  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.

Study Arms (1)

BAY 43-9006, docetaxel, cisplatin

EXPERIMENTAL

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; Drug: docetaxel; Drug: cisplatin

Interventions

BAY 43-9006 DRUG

Given orally

Also known as: Sorafenib (NSC724772), BAY 54-9085 (tosylate salt)

BAY 43-9006, docetaxel, cisplatin

docetaxel DRUG

Given IV

Also known as: Taxotere, RP 56976, NSC #628503

BAY 43-9006, docetaxel, cisplatin

cisplatin DRUG

Given IV

Also known as: Cis-diaminedichloroplatinum, Cis-diaminedichloroplatinum (II), diaminedichloroplatinum, cis-platinum, platinum, Platinol, Platinol-AQ, DDP, CDDP, DACP, NSC 119875.

BAY 43-9006, docetaxel, cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have measurable, histologically confirmed, advanced unresectable or metastatic gastric or GEJ adenocarcinoma; imaging studies must be conducted within 4 weeks of study entry
• For patients with GEJ adenocarcinoma, the tumor location should be specified using the Siewert classification used in other NCI-sponsored Phase II studies in these disease sites
• Patients must have an ECOG performance status of 0-1
• Patients may have had adjuvant chemotherapy or chemoradiation therapy, with or without 5-Fluorouracil if the treatment was performed more than 6 months before any evidence of recurrent or metastatic disease
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Must have the following baseline laboratory values obtained within 2 weeks of registration:
• Absolute Granulocyte Count \>= 1,500/mm\^3
• Platelet Count \>= 100,000/mm\^3
• White Blood Count \>= 3,000/mm\^3
• Serum Creatinine \<= 1.5 mg/dl
• Total Bilirubin \<= 2.0 mg/dl
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/alkaline phosphatase (Alk phos) \<= 2.5 x upper limit of normal
• Patients must be able to take oral medication without crushing, dissolving or chewing tablets

You may not qualify if:

• Prior radiotherapy, chemotherapy or investigational therapies, particularly inhibitors of tyrosine Kinases, signal transduction or angiogenesis in the treatment for their recurrent and/or metastatic gastric or GEJ adenocarcinoma
• Receiving any other investigational agents
• Being pregnant or breast-feeding; all females of childbearing potential must have a blood or urine test within 2 weeks prior to registration to rule out pregnancy
• HIV-positive patients receiving combination antiretroviral therapy are excluded from the study because of possible pharmacokinetic interactions with BAY 43-9006
• Brain metastases
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 43-9006
• Acute active infection with significant clinical intervention per physician's discretion
• Previous or concurrent malignancies are not allowed, except:
• Non-melanoma skin cancer and in situ cervical cancer
• Treated cancer from which the patient has been continuously disease-free for more than five years
• Other uncontrolled intercurrent illnesses including, but not limited to: uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/addictive disorders that would limit compliance with study requirements
• Evidence of bleeding diathesis
• Concurrent cytochrome P450 enzyme-inducing anti-epileptic drugs:
• Phenytoin
• Carbamazepine

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Sun W, Powell M, O'Dwyer PJ, Catalano P, Ansari RH, Benson AB 3rd. Phase II study of sorafenib in combination with docetaxel and cisplatin in the treatment of metastatic or advanced gastric and gastroesophageal junction adenocarcinoma: ECOG 5203. J Clin Oncol. 2010 Jun 20;28(18):2947-51. doi: 10.1200/JCO.2009.27.7988. Epub 2010 May 10.

  PMID: 20458043 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Sorafenib; Docetaxel; Cisplatin; Platinum

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals

Results Point of Contact

• Title: Study Statistician
• Organization: ECOG Statistical Office

617-632-3012

Study Officials

• Weijing Sun, MD

  University of Pennsylvania

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2005
• First Posted: November 15, 2005
• Study Start: October 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: September 1, 2010
• Last Updated: November 24, 2014
• Results First Posted: November 24, 2014

Record last verified: 2013-12

Locations

US (1)