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A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma


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

Thank you

Trial Information

A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma


OBJECTIVES:

Primary

- Determine response in patients with previously treated metastatic or unresectable
gastric or gastroesophageal junction adenocarcinoma treated with bortezomib,
fluorouracil, and leucovorin calcium.

Secondary

- Determine time to progression and overall survival of patients treated with this
regimen.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. One hour after
completion of bortezomib, patients receive leucovorin calcium IV and fluorouracil IV
followed by fluorouracil IV continuously over 46 hours on days 1 and 15. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for survival.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of gastric or gastroesophageal junction adenocarcinoma

- Metastatic or unresectable disease

- Progressive disease after receiving 1 prior chemotherapy regimen for metastatic
disease comprising 1 of the following:

- Fluorouracil

- Cisplatin and irinotecan

- Capecitabine

- Taxanes

- Measurable disease

- No esophageal cancer

- No brain metastases

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- At least 3 months

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin normal

- AST and ALT ≤ 2.5 times upper limit of normal

Renal

- Creatinine ≤ 1.5 mg/dL

Cardiovascular

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No acute ischemia by EKG

- No significant conduction abnormality by EKG, including either of the following:

- Bifasicular block, defined as left anterior hemiblock in the presence of right
bundle branch block

- Second or third degree atrioventricular block

- No history of cardiac or cerebrovascular disease due to hypotension and tachycardia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception before, during, and for 6 months
after study participation

- No ongoing or active infection

- No other uncontrolled illness

- No peripheral neuropathy ≥ grade 2 within the past 2 weeks

- No allergy to boron or mannitol

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 4 weeks since prior immunotherapy

Chemotherapy

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy

- Not specified

Radiotherapy

- More than 4 weeks since prior radiotherapy and recovered

Surgery

- More than 2 weeks since prior major surgery

Other

- No concurrent highly active anti-retroviral therapy for HIV-positive patients

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate as measured by RECIST every 8 weeks

Safety Issue:

No

Principal Investigator

Heinz-Josef Lenz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000410827

NCT ID:

NCT00103103

Start Date:

March 2005

Completion Date:

August 2005

Related Keywords:

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

Name

Location

USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
City of Hope Medical GroupPasadena, California  91105