Gastric CancerPhase 1NCT00601510
Imatinib, Capecitabine, and Cisplatin in Treating Patients With Unresectable or Metastatic Stomach Cancer
A Phase 1 study testing capecitabine, cisplatin and imatinib mesylate in people with Gastric Cancer, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- capecitabine, cisplatin and imatinib mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, D-81675
About this study
Official title: A Phase I Study of Capecitabine, Cisplatin and Imatinib in Patients With Unresectable or Metastatic Gastric Cancer.
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.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerable dose and assess the safety and tolerability of imatinib mesylate in combination with capecitabine and cisplatin in patients with unresectable or metastatic gastric cancer.
Secondary
- To assess the preliminary antitumor activity of this regimen in these patients.
- To assess the response with regard to the expression and/or mutation of the tyrosine kinase receptors PDGF-R and c-kit in gastric cancer.
OUTLINE: This is a dose-escalation study of imatinib mesylate.
Patients receive oral imatinib mesylate once daily on days -4 to 21 in course 1 and on days 1-21 in all subsequent courses, oral capecitabine twice daily on days 1-14, and cisplatin IV on day 1. Courses repeat every 3 weeks* for 12 months in the absence of disease progression or unacceptable toxicity.
NOTE: *First course is 25 days.
After completion of study therapy, patients are followed every 3 weeks.
- Conditions
- Gastric Cancer
- Being tested
- capecitabine, cisplatin, imatinib mesylate
- Keywords
- stage III gastric cancer, stage IV gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
cisplatinDrug
imatinib mesylateDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: capecitabine; Drug: cisplatin; Drug: imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Tolerability
Overall tumor response as assessed by RECIST
Secondary outcomes (3)
Time to progression of disease
Overall survival
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Matthias Ebert, MD, Study chair, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601510
- Sponsor's protocol ID
- CDR0000581134
- Other IDs
- KRDI-TUM-STI571, KRDI-TUM-GLIVEC-CSTI571BDE54, EU-20797, NOVARTIS-KRDI-TUM-STI571, EUDRACT-2006-005792-17
- Status last verified
- Mar 2013
- First submitted
- 25 Jan 2008
- Last updated
- 19 Mar 2013
- Results posted
- No
Publications
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.
PubMed 23228190
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Capecitabine, Cisplatin and Imatinib in Patients With Unresectable or Metastatic Gastric Cancer.
- ClinicalTrials.gov ID
- NCT00601510
- Acronym / sponsor ID
- CDR0000581134
- Conditions
- Gastric Cancer
- Keywords
- stage III gastric cancer, stage IV gastric cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerable dose and assess the safety and tolerability of imatinib mesylate in combination with capecitabine and cisplatin in patients with unresectable or metastatic gastric cancer.
Secondary
- To assess the preliminary antitumor activity of this regimen in these patients.
- To assess the response with regard to the expression and/or mutation of the tyrosine kinase receptors PDGF-R and c-kit in gastric cancer.
OUTLINE: This is a dose-escalation study of imatinib mesylate.
Patients receive oral imatinib mesylate once daily on days -4 to 21 in course 1 and on days 1-21 in all subsequent courses, oral capecitabine twice daily on days 1-14, and cisplatin IV on day 1. Courses repeat every 3 weeks* for 12 months in the absence of disease progression or unacceptable toxicity.
NOTE: *First course is 25 days.
After completion of study therapy, patients are followed every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib mesylate | Experimental | Drug: capecitabine, Drug: cisplatin, Drug: imatinib mesylateImatinib 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine | Drug | Imatinib mesylate |
| cisplatin | Drug | Imatinib mesylate |
| imatinib mesylate | Drug | Imatinib mesylate |
Primary outcome
Safety
Tolerability
Overall tumor response as assessed by RECIST
3 secondary outcomes
Time to progression of disease
Overall survival
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
- Derived from this study: PubMed 23228190Mayr 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Ebert, MD study chair
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing capecitabine, cisplatin and imatinib mesylate in people with Gastric Cancer, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00601510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2013.