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

A Multicenter, Open-Label, Two-Stage, Phase II Study Of PS-341 (LDP-341, NSC # 681239) In Patients With Unresectable Or Metastatic Gastric Adenocarcinoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00074009
Enrollment
Unknown
Registered
2003-12-11
Start date
2003-10-31
Completion date
Unknown
Last updated
2012-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach

Brief 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.

Detailed description

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.

Interventions

DRUGbortezomib

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026