Bortezomib, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Stomach Cancer

NCT00103103 | Terminated Phase 2

• 4 other identifiers: CDR0000410827CCC-PHII-43NCI-5991LAC-USC-3G036
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with fluorouracil and leucovorin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with fluorouracil and leucovorin works in treating patients with metastatic or unresectable stomach cancer.

Conditions

Gastric Cancer

Keywords

recurrent gastric cancer; stage IV gastric cancer; adenocarcinoma of the stomach

Outcome Measures

Primary Outcomes (1)

• Response rate as measured by RECIST every 8 weeks

Secondary Outcomes (4)

• Time to progression every 8 weeks

• Overall survival

• Toxicity every 4 weeks

• Molecular correlates on and off study treatment

Interventions

bortezomib DRUG

fluorouracil DRUG

leucovorin calcium DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of gastric or gastroesophageal junction adenocarcinoma * Metastatic or unresectable disease * Progressive disease after receiving 1 prior chemotherapy regimen for metastatic disease comprising 1 of the following: * Fluorouracil * Cisplatin and irinotecan * Capecitabine * Taxanes * Measurable disease * No esophageal cancer * No brain metastases PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No acute ischemia by EKG * No significant conduction abnormality by EKG, including either of the following: * Bifasicular block, defined as left anterior hemiblock in the presence of right bundle branch block * Second or third degree atrioventricular block * No history of cardiac or cerebrovascular disease due to hypotension and tachycardia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception before, during, and for 6 months after study participation * No ongoing or active infection * No other uncontrolled illness * No peripheral neuropathy ≥ grade 2 within the past 2 weeks * No allergy to boron or mannitol PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * More than 2 weeks since prior major surgery Other * No concurrent highly active anti-retroviral therapy for HIV-positive patients * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• California Cancer Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Bortezomib; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Heinz-Josef Lenz, MD

  University of Southern California

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: March 1, 2005
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: October 13, 2010

Record last verified: 2010-10

Locations

US (5)