Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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)

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	NYWCCC-0103672 NCI-5941, 5941, NCT00061932

Objectives

1. Determine the response rate in patients with previously untreated adenocarcinoma of the gastroesophageal junction or stomach when treated with bortezomib and irinotecan.
2. 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.
3. Compare the toxic effects and recovery from these effects in patients treated with these regimens.

Entry 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

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

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/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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.

Outcomes

Response rate

Gene expression as assessed by microarray at baseline and after completion of study treatment

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.

Trial Contact Information

Trial Lead Organizations

New York Weill Cornell Cancer Center at Cornell University

Allyson Ocean, MD, Protocol chair		Ph: 212-746-2844 Email: ajo9001@med.cornell.edu

Registry Information
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
Trial Start Date		2003-05-22
Trial Completion Date		2004-07-27 (estimated)
Registered in ClinicalTrials.gov		NCT00061932
Date Submitted to PDQ		2003-04-10
Information Last Verified		2007-01-18
NCI Grant/Contract Number		CM17103

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