Imatinib, Capecitabine, and Cisplatin in Treating Patients With Unresectable or Metastatic Stomach Cancer

NCT00601510 | Completed Phase 1

• 6 other identifiers: CDR0000581134KRDI-TUM-STI571KRDI-TUM-GLIVEC-CSTI571BDE54EU-20797NOVARTIS-KRDI-TUM-STI571EUDRACT-2006-005792-17
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Imatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of imatinib when given together with capecitabine and cisplatin in treating patients with unresectable or metastatic stomach cancer.

Conditions

Gastric Cancer

Keywords

stage III gastric cancer; stage IV gastric cancer

Outcome Measures

Primary Outcomes (3)

• Safety

• Tolerability

• Overall tumor response as assessed by RECIST

Secondary Outcomes (3)

• Time to progression of disease

• Overall survival

• Quality of life

Study Arms (1)

Imatinib mesylate

EXPERIMENTAL

Imatinib mesylate 300mg/day(maximum dose will be 800 mg) on day -4, -3, -2, -1, 1, 2, 3 through d21 in combination with capecitabine 1250 mg/m2 twice daily (d1-d14) and iv cisplatin 60mg/m2

Drug: capecitabine; Drug: cisplatin; Drug: imatinib mesylate

Interventions

capecitabine DRUG

Imatinib mesylate

cisplatin DRUG

Imatinib mesylate

imatinib mesylate DRUG

Imatinib mesylate

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed gastric cancer * Unresectable and/or metastatic disease * Incurable with any conventional multimodality approach by interdisciplinary assessment of the local tumor board * Immunohistochemical documentation of c-kit (CD117) and PDGF-R overexpression by tumor if obtainable (preferably on a tumor sample taken within 6 weeks of study entry) * At least one evaluable site of disease according to RECIST criteria * No known brain metastasis or CNS disorder that might alter study compliance or may worsen during or following therapy PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * WBC ≥ 3,000/μL * ANC ≥ 2,000/μL * Platelet count ≥ 100,000/μL * Hemoglobin ≥ 9.0 g/dL * Total bilirubin \< 2 times upper limit of normal (ULN) * SGOT and SGPT \< 2.5 times ULN (5 times ULN if hepatic metastases present) * Glomerular filtration rate ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for up to 3 months after completion of study treatment * No known or documented hypersensitivity against fluoropyrimidines, tyrosine kinase inhibitors, cisplatin, other platinums, or their respective derivatives * No gastrointestinal disorder that might affect the gastrointestinal absorption of capecitabine or imatinib mesylate or ability to swallow for the oral administration of capecitabine or imatinib mesylate * At least 5 years since prior primary malignancy except if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or carcinoma in situ of the cervix * No other concurrent malignant disease * No NYHA class III-IV cardiac disease (i.e., congestive heart failure or myocardial infarction within the past 6 months) * No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection) * No known neuropathy, impaired hearing, history of seizures, and/or psychiatric disorder that might alter study compliance or may worsen during or following therapy * No documented dihydropyrimidine dehydrogenase deficiency * No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis) * No known diagnosis of HIV infection or other serious uncontrolled infections * No significant history of non-compliance to medical regimens or inability to grant reliable informed consent PRIOR CONCURRENT THERAPY: * No chemotherapy or investigational agents within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) unless the disease is rapidly progressing * No prior radiotherapy to ≥ 25% of the bone marrow * No major surgery within the past 2 weeks * No concurrent warfarin or acetaminophen * Therapeutic anticoagulation using heparin or low-molecular weight heparin allowed * No concurrent sorivudine or related substances * No other concurrent anticancer agents, including chemotherapy and biologic agents * No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Related Publications (1)

• Mayr M, Becker K, Schulte N, Belle S, Hofheinz R, Krause A, Schmid RM, Rocken C, Ebert MP. Phase I study of imatinib, cisplatin and 5-fluoruracil or capecitabine in advanced esophageal and gastric adenocarcinoma. BMC Cancer. 2012 Dec 10;12:587. doi: 10.1186/1471-2407-12-587.

  PMID: 23228190 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Cisplatin; Imatinib Mesylate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines

Study Officials

• Matthias Ebert, MD

  Technical University of Munich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: January 28, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2012
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

DE (1)