Status:
COMPLETED
Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Gastroesophageal Junction
Metastatic Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 canc...
Detailed Description
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 an...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Phenobarbital
- Rifampin
- St. John's Wort
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00253370
Start Date
October 1 2005
End Date
September 1 2010
Last Update
November 24 2014
Active Locations (1)
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1
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215