Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00006465
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing capecitabine, irinotecan hydrochloride and oxaliplatin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- capecitabine, irinotecan hydrochloride and oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to Apr 2005
- 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:
- Diagnosis of solid tumor not amenable to curative surgery, radiotherapy, or chemotherapy
- Bidimensionally measurable or evaluable disease
- No brain metastases or primary brain tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC at least 4,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin greater than 10.0 g/dL
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST and ALT less than 2 times normal
Renal:
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- No known hypersensitivity to fluorouracil
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for mitomycin and carmustine) and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior large-field radiotherapy and recovered
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Phase I Study of Oxaliplatin (NSC# 266046), Irinotecan, and Capecitabine in Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors.
- Determine the pharmacokinetic parameters of this regimen in these patients.
- Determine the antitumor response of these patients treated with this regimen.
OUTLINE: This is a dose-escalation study of irinotecan and capecitabine.
Patients receive oxaliplatin IV over 2 hours followed 1 hour later by irinotecan IV over 30 minutes once weekly for 4 weeks. Patients also receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine 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.
PROJECTED ACCRUAL: Approximately 9-15 patients will be accrued for this study within 9-15 months.
- Being tested
- capecitabine, irinotecan hydrochloride, oxaliplatin
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Patients receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose(MTD).
Also called camptothecin-11, irinotecan, irinotecan HCl
Patients receive irinotecan IV over 30 minutes once weekly for 4 weeks (one hour after oxaliplatin). Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose(MTD).
oxaliplatinDrug
Also called diaminocyclohexane oxalatoplatinum, oxalatoplatin, oxalatoplatinum
Patients receive oxaliplatin IV over 2 hours. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors.
Measured: Treatment cycle is four weeks, repeated every six weeks in the absence of disease progression or unacceptable toxicity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 2000
- Primary completionNov 2003
- Study completionApr 2005
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 Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Scot C. Remick, MD, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006465
- Sponsor's protocol ID
- CWRU5Y99
- Other IDs
- U01CA062502, P30CA043703, CWRU-5Y99, NCI-370
- Status last verified
- Jun 2010
- First submitted
- 6 Nov 2000
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Krishnamurthi SS, Brell JM, Hoppel CL, Egorin MJ, Weaver KC, Li X, Ingalls ST, Zuhowski EG, Schluchter MD, Dowlati A, Cooney MM, Gibbons J, Overmoyer BA, Ivy SP, Remick SC. Phase I clinical and pharmacokinetic study of oxaliplatin, irinotecan and capecitabine. Cancer Chemother Pharmacol. 2009 Feb;63(3):441-50. doi: 10.1007/s00280-008-0754-2. Epub 2008 Apr 15.
PubMed 18414865
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Oxaliplatin (NSC# 266046), Irinotecan, and Capecitabine in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00006465
- Acronym / sponsor ID
- CWRU5Y99
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2000
- Primary completion
- Nov 2003 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 27 Jan 2003 (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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors.
- Determine the pharmacokinetic parameters of this regimen in these patients.
- Determine the antitumor response of these patients treated with this regimen.
OUTLINE: This is a dose-escalation study of irinotecan and capecitabine.
Patients receive oxaliplatin IV over 2 hours followed 1 hour later by irinotecan IV over 30 minutes once weekly for 4 weeks. Patients also receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine 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.
PROJECTED ACCRUAL: Approximately 9-15 patients will be accrued for this study within 9-15 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
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 |
|---|---|---|
| capecitabinePatients receive oral capecitabine twice daily on days 1-5 weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose(MTD). | Drug | – |
| irinotecan hydrochlorideAlso: camptothecin-11, irinotecan, irinotecan HClPatients receive irinotecan IV over 30 minutes once weekly for 4 weeks (one hour after oxaliplatin). Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and capecitabine until the maximum tolerated dose(MTD). | Drug | – |
| oxaliplatinAlso: diaminocyclohexane oxalatoplatinum, oxalatoplatin, oxalatoplatinumPatients receive oxaliplatin IV over 2 hours. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. | Drug | – |
Primary outcome
Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors.
Time frame: Treatment cycle is four weeks, repeated every six weeks in the absence of disease progression or unacceptable toxicity.
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 11 Jun 2010.
- Results publication: PubMed 18414865Krishnamurthi SS, Brell JM, Hoppel CL, Egorin MJ, Weaver KC, Li X, Ingalls ST, Zuhowski EG, Schluchter MD, Dowlati A, Cooney MM, Gibbons J, Overmoyer BA, Ivy SP, Remick SC. Phase I clinical and pharmacokinetic study of oxaliplatin, irinotecan and capecitabine. Cancer Chemother Pharmacol. 2009 Feb;63(3):441-50. doi: 10.1007/s00280-008-0754-2. Epub 2008 Apr 15.
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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.
Scot C. Remick, MD principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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, irinotecan hydrochloride and oxaliplatin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center at 1 site in United States.
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 11 Jun 2010. 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 United States. 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?
Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan and capecitabine when given in combination with a fixed dose of oxaliplatin in patients with advanced solid tumors. (time frame: Treatment cycle is four weeks, repeated every six weeks in the absence of disease progression or unacceptable toxicity.). 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 NCT00006465, 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 11 Jun 2010.