A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00068380
First received: September 10, 2003
Last updated: July 21, 2014
Last verified: July 2013
  Purpose

Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. This phase II trial is studying how well imatinib mesylate works in treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer.


Condition Intervention Phase
Recurrent Gastric Cancer
Stage IV Gastric Cancer
Drug: imatinib mesylate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Tumor Response as Determined by the RECIST Criteria [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]
    Will be calculated as the percent of evaluable patients whose best response is a CR or PR.

  • Toxicity in Terms of Type (Organ Affected or Laboratory Determination Such as Absolute Neutrophil Count), Severity (by NCI Common Toxicity Criteria and Nadir or Maximum Values for the Laboratory Measures), Time of Onset, Duration, and Reversibility [ Time Frame: Up to 30 days post treatment ] [ Designated as safety issue: Yes ]
    Tables will be created to summarize these toxicities by type and severity. Baseline information (e.g. the extent of prior therapy) and demographic information will be presented, as well, to describe the patients treated in this Phase II study.

  • Progression-free Survival [ Time Frame: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 30 days post treatment ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: From first day of treatment to time of death due to any cause, assessed up to 30 days post-treatment ] [ Designated as safety issue: No ]
    Will be summarized using the Kaplan-Meier product-limit estimators.

  • Time to Progression [ Time Frame: From first day of treatment to the first observation of disease progression or death due to disease, assessed up to 6 years ] [ Designated as safety issue: No ]
    Will be summarized using the Kaplan-Meier product-limit estimators.

  • Baseline Gene Expression Levels of the Target Genes (PDGF-R and PDGF), Genes Associated With Induction of Apoptosis (Bcl-2, Bax), and Cell Cycle Regulatory Genes (p53, p21, p27 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Will summarized overall and according to response and toxicity (if numbers permit), using medians, quartiles and ranges - or if a transformation is found to render the data compatible with the normal assumptions, with means, standard deviations, and confidence intervals. The association with progression-free survival or overall survival will be assessed by dichotomizing the measures of gene expression at the median (or by previously established cut-points) and constructing Kaplan-Meier plots.


Enrollment: 17
Study Start Date: March 2004
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: imatinib mesylate
Given orally
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the response rate, time to tumor progression, and overall survival in patients with metastatic gastric cancer treated with STI571 who have failed one chemotherapy regimen for metastatic disease.

II. To assess the toxicities of STI571 in these patients. III. To obtain preliminary data on molecular correlates to determine clinical efficacy and toxicity.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (good risk [chemonaïve] vs poor risk [1 prior chemotherapy regimen]).

Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 1-1.5 years.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with metastatic and/or unresectable carcinoma of the stomach, who have measurable disease
  • Life expectancy > 3 months
  • Karnofsky Performance Status > 60%
  • Absence of an active infection
  • Granulocyte count of > 1,500/mm^3
  • Hemoglobin (Hgb) >= 9 mg/dl
  • Serum bilirubin =< 1.5 mg/dl, regardless of liver involvement secondary to tumor
  • Platelets > 100,000/mm^3
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 x the institutional upper limit of normal
  • Calculated creatinine clearance of > 60 ml/min
  • Patients must have signed written informed consent
  • Female patients of child-bearing potential must have a negative blood or urine pregnancy test within two weeks prior to initial study treatment
  • Patients who have had prior chemotherapy or radiation therapy must have recovered from any toxicities prior to study entry
  • Patients must have radiographic imaging to document measurable disease within 28 days prior to initial study therapy

Exclusion Criteria:

  • Diagnosis of resectable carcinoma of the stomach
  • Major surgery within four weeks of study entry
  • Brain metastasis or known seizure disorder
  • Fertile men and women not using an acceptable method of contraception
  • Pregnant or lactating patients are excluded since STI571 may be harmful to the developing fetus and child
  • Patients known to be HIV positive and receiving HAART are excluded because of possibly pharmacological interactions
  • Active peptic ulceration or active gastrointestinal bleeding or any active bleeding disorders
  • Use of therapeutic doses of coumadin (warfarin) as anticoagulation
  • Medical, social, or psychological factors which would prevent the patient from completing the treatment protocol
  • Patients with serious intercurrent illness which would preclude tolerance and completion of the protocol treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068380

Locations
United States, California
City of Hope
Duarte, California, United States, 91010
Sponsors and Collaborators
Investigators
Principal Investigator: Heinz-Josef Lenz Beckman Research Institute
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00068380     History of Changes
Other Study ID Numbers: NCI-2012-02825, 5734, N01CM62209
Study First Received: September 10, 2003
Results First Received: July 21, 2014
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014