Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00544063
Capecitabine, Irinotecan, and Oxaliplatin in Treating Patients With Metastatic Cancer
A Phase 1 study testing irinotecan hydrochloride and oxaliplatin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- irinotecan hydrochloride and oxaliplatin
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Dec 2011
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic carcinoma
- Primary tumor may be present
- No curative therapy available or the patient achieved no response to prior standard therapy
- Nonresectable metastatic disease
- Measurable, evaluable, or nonevaluable disease
- WHO performance status 0-2
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- Life expectancy ≥ 12 weeks
- ANC ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Bilirubin < 1.25 times upper limit of normal (ULN) (1.5 times ULN if due to liver metastases)
- Transaminases < 3 times ULN (5 times ULN if due to liver metastases)
- Alkaline phosphatase ≤ 3 times ULN
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance > 30 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
- At least 4-6 weeks since prior anticancer chemotherapy
- Exclusions criteria:
- Prior chemotherapy with any of the study drugs
- Prior major intestinal resection
- Concurrent participation in another clinical study
Who cannot join
- Symptomatic brain metastases or carcinomatous meningitis
- PATIENT CHARACTERISTICS:
- Severe concurrent infection or major organ failure, including any of the following:
- Cardiac disease
- Diabetic decompensation
- Clinically active infection
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- Prior severe toxicity from fluorouracil
- Intestinal obstruction or subobstruction
- Malabsorption syndrome
- Peripheral neuropathy
- Uncontrolled epilepsy
- PRIOR CONCURRENT THERAPY:
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
Marc Ychou, MD, PhD, 33-4-6761-3066, mychou@valdorel.fnclcc.fr
About this study
Official title: Phase I Study Evaluating the Feasibility of Chemotherapy With Capecitabine, Irinotecan, and Oxaliplatin in Patients With Metastatic Carcinoma
RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with irinotecan and oxaliplatin in treating patients with metastatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicities of capecitabine.
Secondary
- Determine the recommended phase II dose of capecitabine.
- Define the toxicity profile.
- Evaluate potential antitumor activity in terms of objective response, duration of response, and time to disease progression.
- Evaluate the pharmacokinetic profile of capecitabine and irinotecan hydrochloride.
OUTLINE: This is a dose-escalation study of capecitabine conducted in two parts.
- Part I: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1 and oral capecitabine twice daily on days 1-7. Treatment repeats every 2 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
Cohorts of up to 6 patients receive escalating doses (up to 5 dosages) of capecitabine. The maximum tolerated dose (MTD) is defined as the dose at which 50% of patients experience toxicity during the first 2 courses of therapy.
- Part II: Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on day 1 and oral capecitabine on days 1-7. Treatment repeats every 2 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
Cohorts of up to 6 patients receive escalating doses (up to 7 dosages) of capecitabine. The MTD is defined as in part I.
- Being tested
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of capecitabine
Dose-limiting toxicities
Secondary outcomes (6)
Recommended phase II dose of capecitabine
Toxicity profile
Objective response
Duration of response
Time to disease progression
Pharmacokinetic profile of capecitabine and irinotecan hydrochloride
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Non-randomised
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Marc Ychou, MD, PhD, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544063
- Sponsor's protocol ID
- CDR0000564073
- Other IDs
- CLCC-XEL-IRIN-OX, INCA-RECF0416, VA-XIOX, EudraCT-2005-004567-38
- Status last verified
- Jul 2009
- First submitted
- 13 Oct 2007
- Last updated
- 15 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Evaluating the Feasibility of Chemotherapy With Capecitabine, Irinotecan, and Oxaliplatin in Patients With Metastatic Carcinoma
- ClinicalTrials.gov ID
- NCT00544063
- Acronym / sponsor ID
- CDR0000564073
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2011 (estimated)
- First posted
- 16 Oct 2007 (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, such as capecitabine, irinotecan, and oxaliplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with irinotecan and oxaliplatin in treating patients with metastatic cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and dose-limiting toxicities of capecitabine.
Secondary
- Determine the recommended phase II dose of capecitabine.
- Define the toxicity profile.
- Evaluate potential antitumor activity in terms of objective response, duration of response, and time to disease progression.
- Evaluate the pharmacokinetic profile of capecitabine and irinotecan hydrochloride.
OUTLINE: This is a dose-escalation study of capecitabine conducted in two parts.
- Part I: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1 and oral capecitabine twice daily on days 1-7. Treatment repeats every 2 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
Cohorts of up to 6 patients receive escalating doses (up to 5 dosages) of capecitabine. The maximum tolerated dose (MTD) is defined as the dose at which 50% of patients experience toxicity during the first 2 courses of therapy.
- Part II: Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on day 1 and oral capecitabine on days 1-7. Treatment repeats every 2 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.
Cohorts of up to 6 patients receive escalating doses (up to 7 dosages) of capecitabine. The MTD is defined as in part I.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically confirmed metastatic carcinoma
- Measurable, evaluable, or nonevaluable disease
- WHO performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 2,000/mm^3
Key exclusion criteria (12 listed)
- Symptomatic brain metastases or carcinomatous meningitis
- Severe concurrent infection or major organ failure, including any of the following:
- Prior severe toxicity from fluorouracil
- Intestinal obstruction or subobstruction
- Malabsorption syndrome
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 |
|---|---|---|
| irinotecan hydrochloride | Drug | – |
| oxaliplatin | Drug | – |
Primary outcome
Maximum tolerated dose of capecitabine
Dose-limiting toxicities
6 secondary outcomes
Recommended phase II dose of capecitabine
Toxicity profile
Objective response
Duration of response
Time to disease progression
Pharmacokinetic profile of capecitabine and irinotecan hydrochloride
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
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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.
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France
Marc Ychou, MD, PhD
Institut du Cancer de Montpellier - Val d'Aurelle
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 irinotecan hydrochloride and oxaliplatin in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 12 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 15 Dec 2009. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of capecitabine. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2009.