A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma
18 Years
N/A
Both
Gastric Cancer
Trial Information
A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma
OBJECTIVES:
Primary
- Determine response in patients with previously treated metastatic or unresectable
gastric or gastroesophageal junction adenocarcinoma treated with bortezomib,
fluorouracil, and leucovorin calcium.
Secondary
- Determine time to progression and overall survival of patients treated with this
regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. One hour after
completion of bortezomib, patients receive leucovorin calcium IV and fluorouracil IV
followed by fluorouracil IV continuously over 46 hours on days 1 and 15. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for survival.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate as measured by RECIST every 8 weeks
Safety Issue:
No
Principal Investigator
Heinz-Josef Lenz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
USC/Norris Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000410827
NCT ID:
NCT00103103
Start Date:
March 2005
Completion Date:
August 2005
Related Keywords:
- Gastric Cancer
- recurrent gastric cancer
- stage IV gastric cancer
- adenocarcinoma of the stomach
- Adenocarcinoma
- Stomach Neoplasms
Name | Location |
|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
| City of Hope Medical Group | Pasadena, California 91105 |
