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


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Manish A. Shah, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000341565

NCT ID:

NCT00074009

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Gastric Cancer
  • recurrent gastric cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • adenocarcinoma of the stomach
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Queens Cancer Center of Queens HospitalJamaica, New York  11432