Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach (Group Two Closed to Accrual as of 9/19/2006) - Full Text View

Sponsor:	Weill Medical College of Cornell University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00061932

Purpose

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with irinotecan may kill more tumor cells.

PURPOSE: This phase II trial is studying how well bortezomib with or without irinotecan works in treating patients with gastroesophageal junction or stomach cancer that can not be removed by surgery.

Condition	Intervention	Phase
Gastric Cancer	Drug: bortezomib Drug: irinotecan hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Of PS341 Alone Or In Combination With Irinotecan In Patients With Adenocarcinoma Of The Gastroesophageal Junction (GEJ) Or Stomach

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride Bortezomib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Gene expression as assessed by microarray at baseline and after completion of study treatment [ Designated as safety issue: No ]

Estimated Enrollment:	58
Study Start Date:	May 2003
Estimated Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stratum 1 (previously untreated): Experimental Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.	Drug: bortezomib Given IV Drug: irinotecan hydrochloride Given IV
Stratum 2 (previously treated, closed to accrual 9/19/2006: Experimental Patients receive bortezomib as in stratum 1.	Drug: bortezomib Given IV

Detailed Description:

OBJECTIVES:

Determine the response rate in patients with previously untreated adenocarcinoma of the gastroesophageal junction or stomach when treated with bortezomib and irinotecan.
Determine the response rate in patients with previously treated (closed to accrual as of 9/19/2006) adenocarcinoma of the gastroesophageal junction or stomach when treated with bortezomib.
Compare the toxic effects and recovery from these effects in patients treated with these regimens.

OUTLINE: Patients are stratified (stratum 2 closed to accrual as of 9/19/2006) according to prior chemotherapy for advanced disease (yes vs no).

Stratum 1 (Previously untreated patients): Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.
Stratum 2 (Previously treated patients) (closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.

In both strata, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 33-58 patients (18-33 previously untreated patients and 15-25 previously treated patients [(closed to accrual as of 9/19/2006)]) will be accrued for this study within 12 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed adenocarcinoma of the gastroesophageal junction or stomach
- Unresectable disease
Unidimensionally measurable disease defined as at least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
No known brain metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2 OR
Karnofsky 60-100%

Life expectancy

More than 6 weeks

Hematopoietic

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin normal
AST/ALT no greater than 2.5 times upper limit of normal

Renal

Creatinine normal

Cardiovascular

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior allergic reactions attributed to compounds of similar chemical or biological composition to bortezomib or other agents in study
No other malignancy within the past 5 years except early stage squamous cell skin cancer or carcinoma of the cervix that can be treated locally
No psychiatric illness or social situation that would preclude study compliance
No ongoing active infection
No other concurrent uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Prior adjuvant chemotherapy for resected disease allowed
No more than 1 prior systemic chemotherapy regimen for advanced disease
No other concurrent chemotherapy

Endocrine therapy

Not specified

Radiotherapy

More than 4 weeks since prior radiotherapy and recovered
No concurrent radiotherapy

Surgery

See Chemotherapy

Other

More than 4 weeks since prior photodynamic therapy (except for relieving esophageal obstruction that could not be treated with laser, stent, or dilation)
No concurrent photodynamic therapy
No concurrent commercial or other investigational agents or therapies intended to treat the malignancy
No concurrent combination antiretroviral therapy for HIV-positive patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061932

Locations

United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10467
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
Mount Sinai Medical Center
New York, New York, United States, 10029
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Canada, Ontario
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

Weill Medical College of Cornell University

National Cancer Institute (NCI)

Investigators

Study Chair:

Allyson J. Ocean, MD

Weill Medical College of Cornell University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000302448, NYWCCC-0103672, NCI-5941
Study First Received:	June 5, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00061932 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Irinotecan
Bortezomib
Enzyme Inhibitors
Pharmacologic Actions
Camptothecin

Protease Inhibitors
Neoplasms
Neoplasms by Site
Digestive System Diseases
Stomach Diseases
Therapeutic Uses
Stomach Neoplasms
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 05, 2009