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Solid TumorsPhase 1NCT00697502

Study of Capecitabine In Patients With Solid Tumors

A Phase 1 study testing Capecitabine in people with Solid Tumors, run by National University Hospital, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hypothesis: Patients with TYMS 2R/2R or 2R/3R appear to be more sensitive to fluoropyrimidines, conferring a higher risk of grade 3-4 fluoropyrimidine related toxicity and a higher response rate compared with 3R/3R. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteSingapore
Study dates
May 2007to May 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

Who may be able to join

  • Cytologically or histologically confirmed advanced or metastatic non- hematologic malignancy that had failed previous therapies or cancer for which there are no standard treatment options.
  • Presence of at least one uni-dimensional measurable lesion as defined by the RECIST criteria.
  • Required genotype characteristics:
  • Group 1: TSER genotype 2R/2R or 2R/3R
  • Group 2: TSER genotype 3R/3R
  • Able to swallow capsules
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  • Age>=18 years
  • Kanorfsky performance status of at least 70% or ECOG performance status <2 (Appendix A)
  • Life expectancy of at least 3 months
  • Hb >=9 g/dL
  • ANC >=1.5 x 10^9/L
  • Platelet count >=100 x 10^9/L.
  • Total bilirubin and serum creatinine <=1.5x upper limits of normal reference range (ULN)
  • Alkaline phosphatase, AST/ALT levels <=2.5x upper limit of normal. If hepatic metastases are present, these parameters could be <=10x the ULN.
  • Women of reproductive age and men must agree to practice effective contraception during the entire study period. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child- bearing potential. Females with childbearing potential must have a negative serum pregnancy test within 7days prior to study enrolment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Signed written informed consent

Who cannot join

  • Received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational therapy within 28 days prior to study drug administration (6 weeks for mitomycin or nitroureas) and not recovered.
  • Patients who have not recovered from major surgery
  • Any woman pregnant or lactating.
  • Known CNS metastases
  • Renal impairment with a creatinine clearance <=50mL/min (as calculated according to Cockcroft and Gault formula) or serum creatinine > ULN
  • Clinically significant cardiac disease, eg. Congestive cardiac failure, symptomatic coronary heart disease, cardiac arrhythmia or myocardial infarction within the last 12 months.
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  • Known HIV infection
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, other serious uncontrolled concomitant disease, psychiatric illness/ social situation that would limit study compliance.
  • Known allergies to any component of the study drug
  • Lack of physical integrity of the upper gastrointestinal tract or those with malabsorption syndrome
  • Organ allografts
  • Known dihydropyrimidine dehydrogenase deficiency

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National University Hospital

    Singapore

Other trials in Singapore

About this study

Official title: A Phase I Study of Capecitabine In Patients With Solid Tumors

Hypothesis:

Patients with TYMS 2R/2R or 2R/3R appear to be more sensitive to fluoropyrimidines, conferring a higher risk of grade 3-4 fluoropyrimidine related toxicity and a higher response rate compared with 3R/3R. The genotype 3R/3R is more common in East Asia and is associated with greater tolerability to fluoropyrimidine as measured by lower toxicity but also lower response rates. As sensitivity to fluoropyrimidine appears to be affected by TYMS genotype, we hypothesise that patients with TYMS 3R/3R are more tolerant to standard doses of capecitabine and require higher doses to overcome fluoropyrimidine resistance. We designed this study to develop TYMS genotype specific dosing of capecitabine.

Read more

Aims:

  1. To determine the maximal tolerated dose (MTD) of capecitabine twice a day for two weeks followed by one week rest period (intermittent schedule) in patients with the advanced/ and or metastatic cancer based on TYMS genotype.
  2. To determine a suitable phase II dose of intermittent schedule capecitabine.
  3. To determine the safety and toxicity of this regimen.
  4. To perform plasma pharmacokinetics of capecitabine.
  5. To determine the relationship between genes of relevance in the fluoropyrimidine pathway with pharmacokinetics and toxicity.
Conditions
Solid Tumors
Being tested
Capecitabine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Also called XELODA

    Capecitabine (XELODA) is supplied as biconvex, oblong film-coated tablets for oral administration and will be obtained from NUH Cancer Centre pharmacy.

    Each light peach-colored tablet contains 150 mg capecitabine and each peach-colored tablet contains 500 mg capecitabine. Capecitabine is to be administered orally within 30 minutes after the end of a meal (breakfast, dinner). Tablets should be swallowed with about 200 mL of water (not fruit juices). Capecitabine will be administered for 14 days followed by a 7 day rest period.

Study groups in NCT00697502
Study groupRoleWhat they receive
Group 2: TSER 3R/3RExperimentalCohorts of 3-6 patients in each genotype group will receive escalating doses of capecitabine until MTD is reached. Once MTD is determined, an additional 6-9 patients (for a total of 12 patients) will receive treatment at that dose.
Receives: Drug: Capecitabine
Group 1: TSER 2R/2R or 2R/3RExperimentalCohorts of 3-6 patients in this genotype group will receive escalating doses of capecitabine until MTD is reached. Once MTD is determined, an additional 6-9 patients (for a total of 12 patients) will receive treatment at that dose.
Receives: Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the maximal tolerated dose (MTD) of capecitabine twice a day for two weeks followed by one week rest period (intermittent schedule) in patients with the advanced/ and or metastatic cancer based on TYMS genotype.

    Measured: 4 weeks

Secondary outcomes (1)

  1. Plasma concentrations of capecitabine and its metabolites

    Pharmacokinetic sampling will be performed during cycle 1 on days 1 and 14 at the following time points:

    Baseline (predose), and 15 min, 30 min, 1 hr, 2 hr, 4 hr, 5 hr and 6 hr after dosing. Blood samples will be centrifuged at 1500 g and 4oC for 10 min and supernatant plasma removed and stored below -20oC until analysis. Plasma concentrations of capecitabine and its metabolites will be quantified by a validated liquid chromatography with mass-spectrometry detection (LC-MS-MS) method

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

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
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00697502
Sponsor's protocol ID
PG03/32/06
Status last verified
Oct 2012
First submitted
11 Jun 2008
Last updated
1 Nov 2012
Results posted
No
Data monitoring committee
No

Publications

  • Soong R, Diasio RB. Advances and challenges in fluoropyrimidine pharmacogenomics and pharmacogenetics. Pharmacogenomics. 2005 Dec;6(8):835-47. doi: 10.2217/14622416.6.8.835.

    PubMed 16296946

  • Park DJ, Stoehlmacher J, Zhang W, Tsao-Wei D, Groshen S, Lenz HJ. Thymidylate synthase gene polymorphism predicts response to capecitabine in advanced colorectal cancer. Int J Colorectal Dis. 2002 Jan;17(1):46-9. doi: 10.1007/s003840100358.

    PubMed 12018454

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Capecitabine in people with Solid Tumors, run by National University Hospital, 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?

The sponsor lists 16 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: finished, as of the sponsor's last update on 1 Nov 2012. 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?

To determine the maximal tolerated dose (MTD) of capecitabine twice a day for two weeks followed by one week rest period (intermittent schedule) in patients with the advanced/ and or metastatic cancer based on TYMS genotype. (time frame: 4 weeks). 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 NCT00697502, which also lists 2 linked publications.

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 1 Nov 2012.

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