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Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Albert Einstein College of Medicine of Yeshiva University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00064259
  Purpose

RATIONALE: Drugs used in chemotherapy such as cisplatin and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs.

PURPOSE: This phase I/II trial is studying the side effects and best dose of oblimersen when given with cisplatin and fluorouracil and to see how well they work in treating patients with locally advanced, recurrent, or metastatic cancer of the esophagus, gastroesophageal junction, or stomach.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: cisplatin
Drug: fluorouracil
Drug: oblimersen
Phase I
Phase II

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Stomach Cancer
Drug Information available for: Cisplatin Fluorouracil Oblimersen sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
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

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

Primary Outcome Measures:
  • Analysis of biopsy specimens [ Designated as safety issue: No ]
  • Drug effect as measured by changes in microarray expression patterns [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patterns of gene expression pre- and post-treatment [ Designated as safety issue: No ]

Study Start Date: June 2003
Detailed Description:

OBJECTIVES:

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

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.

PROJECTED ACCRUAL: 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.

  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 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

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/mm^3
  • Platelet count at least 100,000/mm^3

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])

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064259

Locations
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Mount Sinai Medical Center
New York, New York, United States, 10029
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
North Shore University Hospital
Manhasset, New York, United States, 11030
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Study Chair: Andreas Kaubisch, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

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

Study ID Numbers: CDR0000310160, AECM-0266, NCI-5835, AECM-0302032
Study First Received: July 8, 2003
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00064259  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the esophagus
adenocarcinoma of the stomach
squamous cell carcinoma of the esophagus
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer
recurrent gastric cancer
stage III gastric cancer
stage IV gastric cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Squamous cell carcinoma
Esophageal Neoplasms
Stomach cancer
Recurrence
Carcinoma
Epidermoid carcinoma
Digestive System Diseases
Stomach Diseases
Cisplatin
Fluorouracil
Stomach Neoplasms
Head and Neck Neoplasms
Carcinoma, squamous cell
Gastrointestinal Neoplasms
Esophageal Diseases
Carcinoma, Squamous Cell
Adenocarcinoma
Esophageal neoplasm

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009