A Multicenter, Open-Label, Two-Stage, Phase II Study Of PS-341 (LDP-341, NSC # 681239) In Patients With Unresectable Or Metastatic Gastric Adenocarcinoma
Data Collection
Adenocarcinoma+9
+ Carcinoma
+ Digestive System Diseases
Treatment Study
Summary
Study start date: October 1, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the efficacy of bortezomib in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Secondary * Determine the toxicity of this drug in these patients. * Determine possible predictors of response to this drug, using pretreatment tumor immunohistochemistry, in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study within 5-12 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma * Siewert's class II or III disease * Measurable disease * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No history of known or active brain metastases or primary brain tumors PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% OR * ECOG 0-2 Life expectancy * Not specified Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL * AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Renal * Creatinine no greater than 1.5 mg/dL Cardiovascular * No prior cerebrovascular event * No prior orthostatic hypotension * No myocardial infarction within the past 6 months * No peripheral vascular disease requiring surgical management * No evidence of acute ischemia or significant conduction abnormality by EKG Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 2 months after study participation * No evidence of peripheral neuropathy * No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib * No other malignancy within the past 3 years except basal cell skin cancer, carcinoma in situ of the cervix, or adequately treated nonmetastatic prostate cancer * No ongoing or active infection * No psychiatric illness or social situation that would preclude study participation * No other concurrent uncontrolled illness that would preclude study participation * No other medical condition or reason that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * More than 3 weeks since prior immunotherapy * No concurrent biological or immunological agents Chemotherapy * No more than 1 prior chemotherapy regimen (including adjuvant chemotherapy) * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * Recovered from all prior therapy * No other concurrent investigational agents * No other concurrent anticancer agent or therapy
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Queens Cancer Center of Queens Hospital
Jamaica, United StatesMemorial Sloan-Kettering Cancer Center
New York, United StatesUniversity of Wisconsin Comprehensive Cancer Center
Madison, United States