Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: bortezomib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Open-Label, Two-Stage, Phase II Study Of PS-341 (LDP-341, NSC # 681239) In Patients With Unresectable Or Metastatic Gastric Adenocarcinoma |
| Study Start Date: | October 2003 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, New York | |
| Queens Cancer Center of Queens Hospital | |
| Jamaica, New York, United States, 11432 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-3236 | |
| Principal Investigator: | Manish A. Shah, MD | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Gary K. Schwartz, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00074009 History of Changes |
| Other Study ID Numbers: | CDR0000341565, MSKCC-03101, NCI-6003 |
| Study First Received: | December 10, 2003 |
| Last Updated: | February 11, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent gastric cancer stage III gastric cancer stage IV gastric cancer adenocarcinoma of the stomach |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013