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

Alternate Title

Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	Over 18	NCI	AECM-0266 NCI-5835, AECM-0302032, NCT00064259, 5835

Objectives

1. Determine the maximum tolerated dose of oblimersen administered with cisplatin and fluorouracil in patients with advanced esophageal, gastroesophageal junction, or gastric cancer.
2. Determine the toxic effects of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or stomach
  • Squamous cell carcinoma of the esophagus also eligible



• Locally advanced, recurrent, or metastatic disease not amenable to complete surgical resection or definitive radiotherapy



• Clinically evaluable disease



• Measurable disease or clinically evaluable disease
  • Patients with inaccessible tumor tissue must have at least 1 measurable tumor deposit



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent growth factors during the first course of study therapy

Chemotherapy

• No more than 1 prior chemotherapy regimen for advanced, recurrent, or metastatic disease
  • Prior significant full-dose chemotherapy (at least 2 months of therapy) during primary treatment is considered a prior regimen of chemotherapy (unless at least 6 months have elapsed since completion of treatment)
  • An additional chemotherapy regimen allowed for recurrent or progressive disease more than 6 months after the completion of prior significant chemotherapy
• At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered

Surgery

• Prior surgery allowed

Other

• More than 4 weeks since prior photodynamic therapy
• No prior oblimersen
• No other concurrent investigational agents
• No concurrent combination antiretroviral therapy for HIV-positive patients
• Concurrent photodynamic therapy for obstruction untreatable by stent, laser, or dilation allowed

Patient Characteristics:

Age

• Over 18

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• More than 12 weeks

Hematopoietic

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

Hepatic

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

Renal

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

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 barrier contraception
• No prior allergic reaction attributed to compounds of similar chemical or biological composition to antisense oligonucleotides, cisplatin, fluorouracil, or other study agents
• No other concurrent uncontrolled illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• Willing to undergo 2 biopsies (for patients with accessible tumor only, defined as tumors reachable by esophagogastroduodenoscopy OR metastases which can be biopsied with commonly utilized methods [e.g., CT-guided biopsy])

Expected Enrollment

Approximately 37-97 patients (3-36 for phase I and 34-67 for phase II) will be accrued for this study within 15-18 months.

Outcomes

Analysis of biopsy specimens
Drug effect as measured by changes in microarray expression patterns

Patterns of gene expression pre- and post-treatment

Outline

This is a pilot, multicenter, dose-escalation study of oblimersen.

• Phase I: Patients receive oblimersen IV continuously on days 1-7, fluorouracil IV continuously on days 4-8, and cisplatin IV on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

  Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 12 patients are treated at the MTD.




• Phase II: Patients receive treatment as in phase I with oblimersen at the MTD.

Trial Contact Information

Trial Lead Organizations

Albert Einstein Cancer Center at Albert Einstein College of Medicine

Andreas Kaubisch, MD, Protocol chair		Ph: 718-920-4826

Registry Information
Official Title		A Phase I/II Study of Genasense (G3139) in Combination with Cisplatin and Fluorouracil in Patients with Advanced Esophageal, Gastro-Esophageal Junction and Gastric Cancer
Trial Start Date		2003-06-18
Registered in ClinicalTrials.gov		NCT00064259
Date Submitted to PDQ		2003-05-27
Information Last Verified		2006-11-10
NCI Grant/Contract Number		CM62204

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