Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00731276
Irinotecan in Treating Asian Patients With Solid Tumors
A Phase 1 study testing irinotecan hydrochloride, pharmacogenomic studies and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan in treating Asian patients with solid tumors. Read more about this study
- Who is it for?
- Ages 21 to 120 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- irinotecan hydrochloride, pharmacogenomic studies and pharmacological study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Apr 2008to Apr 2016
- 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 21 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed solid tumors
- Failed at least one line of prior chemotherapy
- Must belong to either Chinese, Malay, or Indian ethnic groups
- Previously irradiated disease allowed provided marker lesions not within the irradiated field
- Presence of at least one bidimensionally measurable, non-CNS indicator lesion, defined by radiologic study (including CT or MRI scan, ultrasound, or chest X-ray) or physical exam, meeting 1 of the following criteria:
- Measurable disease on CT or MRI scan must have one diameter ≥ 1 cm and one diameter ≥ 2 cm
- Measurable disease on chest X-ray or ultrasound must have both diameters ≥ 2 cm
- Palpable tumor masses that cannot be evaluated radiologically must have two diameters ≥ 2 cm
- Measurable skin lesion must have at least one diameter ≥ 1 cm
- No unidimensionally measurable or evaluable only disease
- No known brain or leptomeningeal metastasis
- No uncontrolled large pleural effusions
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Absolute granulocyte count ≥ 1,000/µL
- WBC ≥ 3,500/µL
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100,000/µL
- Serum total bilirubin ≤ 2.0 mg/dL
- ALT/AST < 2.5 times normal (5 times normal in patients with known metastatic disease in the liver)
- Creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No medical problems severe enough to prevent compliance with the study requirements
- No prior malignancies, except for adequately treated basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for 5 years
- No active or uncontrolled infection
- No pre-existing cardiac disease, including congestive heart failure, arrhythmia requiring treatment, or myocardial infarction within the past 3 months
- No pneumonitis
- No uncontrolled diabetes mellitus (i.e., random blood glucose > 200 mg/dL)
- No inflammatory bowel disease
PRIOR CONCURRENT THERAPY:
- At least 1 week since prior and no concurrent ketoconazole
- More than 4 weeks since prior chemotherapy or radiotherapy
- At least 2 weeks since prior and no concurrent Hypericum perforatum (St. John wort)
- No prior irinotecan hydrochloride
- No concurrent investigational antineoplastic therapy or other investigational drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan in treating Asian patients with solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- To determine the dose-limiting toxicity and maximum tolerated dose of irinotecan hydrochloride according to the genotype status of Asian patients with solid tumors.
Secondary
- To investigate the pharmacokinetics of irinotecan hydrochloride and its metabolites SN-38 and SN-38G.
- To evaluate time to tumor response, response duration, and time to progression in these patients.
OUTLINE: Patients are stratified according to genotype status (UGT1A1*28 vs UGT1A1*6)
Patients receive irinotecan hydrochloride IV once weekly for 3 weeks. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for pharmacogenetic, pharmacokinetic, and pharmacodynamic studies.
- Being tested
- irinotecan hydrochloride, pharmacogenomic studies, pharmacological study
- 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.
pharmacogenomic studiesOther
| Study group | Role | What they receive |
|---|---|---|
| Four Regimens | Other | The study has four type of regimens, and dosing of irinotecan depends on genotype of patient.
Four Regimens are:
1. Weekly Irinotecan (Irinotecan given at day 1, 8 and 15) every four weekly
2. Weekly Xeliri ( Irinotecan given at day 1, 8 and 15)+ (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly
3. Three-weekly Xeliri (Irinotecan given at day 1 only) + (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly
4. Two-weekly FOLFIRI (Irinotecan given at day 1 only) + (CI Fluorouracil 600mg/m2 over 22hrs, IV Folinic Acid 200mg/m2 over 2hrs and IVP Fluorouracil 400mg/m2) every two weekly Receives: Drug: irinotecan hydrochloride; Other: pharmacogenomic studies; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
Measured: No time frame defined. Trial is still recruiting.
Maximum tolerated dose
Measured: No time frame defined. Trial is still recruiting.
Secondary outcomes (4)
Pharmacokinetics
Measured: No time frame defined. Trial is still recruiting.
Time to tumor response
Measured: No time frame defined. Trial is still recruiting.
Time to progression
Measured: No time frame defined. Trial is still recruiting.
Response duration
Measured: No time frame defined. Trial is still recruiting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study start3 Apr 2008
- Primary completionNov 2015
- Study completionApr 2016
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.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Su Pin Choo, MD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731276
- Sponsor's protocol ID
- CDR0000601207
- Other IDs
- SINGAPORE-NCC0703
- Status last verified
- Mar 2017
- First submitted
- 7 Aug 2008
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients
- ClinicalTrials.gov ID
- NCT00731276
- Acronym / sponsor ID
- CDR0000601207
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 3 Apr 2008 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Aug 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: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan in treating Asian patients with solid tumors.
Detailed description
OBJECTIVES:
Primary
- To determine the dose-limiting toxicity and maximum tolerated dose of irinotecan hydrochloride according to the genotype status of Asian patients with solid tumors.
Secondary
- To investigate the pharmacokinetics of irinotecan hydrochloride and its metabolites SN-38 and SN-38G.
- To evaluate time to tumor response, response duration, and time to progression in these patients.
OUTLINE: Patients are stratified according to genotype status (UGT1A1*28 vs UGT1A1*6)
Patients receive irinotecan hydrochloride IV once weekly for 3 weeks. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically for pharmacogenetic, pharmacokinetic, and pharmacodynamic studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Four Regimens | Other | Drug: irinotecan hydrochloride, Other: pharmacogenomic studies, Other: pharmacological studyThe study has four type of regimens, and dosing of irinotecan depends on genotype of patient. Four Regimens are: 1. Weekly Irinotecan (Irinotecan given at day 1, 8 and 15) every four weekly 2. Weekly Xeliri ( Irinotecan given at day 1, 8 and 15)+ (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly 3. Three-weekly Xeliri (Irinotecan given at day 1 only) + (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly 4. Two-weekly FOLFIRI (Irinotecan given at day 1 only) + (CI Fluorouracil 600mg/m2 over 22hrs, IV Folinic Acid 200mg/m2 over 2hrs and IVP Fluorouracil 400mg/m2) every two weekly |
Who may qualify
- Ages
- 21 to 120 years
- 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 |
|---|---|---|
| irinotecan hydrochloride | Drug | Four Regimens |
| pharmacogenomic studies | Other | Four Regimens |
| pharmacological study | Other | Four Regimens |
Primary outcome
Dose-limiting toxicity
Time frame: No time frame defined. Trial is still recruiting.
Maximum tolerated dose
Time frame: No time frame defined. Trial is still recruiting.
4 secondary outcomes
Pharmacokinetics
Time frame: No time frame defined. Trial is still recruiting.
Time to tumor response
Time frame: No time frame defined. Trial is still recruiting.
Time to progression
Time frame: No time frame defined. Trial is still recruiting.
Response duration
Time frame: No time frame defined. Trial is still recruiting.
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 31 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Su Pin Choo, MD principal investigator
National Cancer Centre, Singapore
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, pharmacogenomic studies and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 31 Mar 2017. 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 Singapore. 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?
Dose-limiting toxicity (time frame: No time frame defined. Trial is still recruiting.). 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 31 Mar 2017.