Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib

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