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

NCT00068380 | Completed Phase 2 Results

• 3 other identifiers: NCI-2012-028255734N01CM62209
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Gastric Cancer; Stage IV Gastric Cancer

Outcome Measures

Primary Outcomes (6)

• Response Rate

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by X-Ray, MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  Up to 6 years

• Toxicity Summary

  Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. Grade 3 and above adverse events possibly, probably or definitely related to treatment.

  Up to 30 days post treatment

• Progression-free Survival

  Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  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

• Overall Survival

  Will be summarized using the Kaplan-Meier product-limit estimators.

  From first day of treatment to time of death due to any cause, assessed up to 5 years post-treatment

• Time to Treatment Failure

  Defined as the time from start of treatment to the discontinuation of treatment for any reason, including disease progression, treatment toxicity, patient preference, or death Will be summarized using the Kaplan-Meier product-limit estimators. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  From first day of treatment until discontinuation of treatment, assessed up to 30 days post treatment

• 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

  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.

  Baseline

Study Arms (1)

Treatment (imatinib mesylate)

EXPERIMENTAL

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; Other: laboratory biomarker analysis

Interventions

imatinib mesylate DRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec

Treatment (imatinib mesylate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (imatinib mesylate)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Limitations and Caveats

In the first stage none of the 17 patients responded (CR/PR) to treatment. Due to budget constraints and recent reprioritizations, CTEP closed the study to accrual.

Results Point of Contact

• Title: DCC Project Administrator
• Organization: California Cancer Consortium

CCCP@coh.org

626-256-4673

Study Officials

• Heinz-Josef Lenz

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: March 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 11, 2018
• Results First Posted: August 12, 2014

Record last verified: 2018-06

Locations

US (1)