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Colorectal CancerPhase 1/2NCT00496704

Gemcitabine, Capecitabine, and Oxaliplatin as Second-Line Therapy in Treating Patients With Advanced Colorectal Cancer Previously Treated With Irinotecan

A Phase 1/2 study testing capecitabine, gemcitabine hydrochloride and oxaliplatin in people with Colorectal Cancer, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
capecitabine, gemcitabine hydrochloride and oxaliplatin
How many people
56 participants
Where
1 siteSouth Korea
Study dates
Jan 2007to Aug 2009
Phase
Phase 1/2
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 advanced colorectal adenocarcinoma
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Must have received prior irinotecan hydrochloride with a progression-free interval of < 3 months
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
  • Creatinine ≤ 1.5 times ULN
  • No significant cardiac abnormalities by ECG
  • No known hypersensitivity to the study drugs or any of their components
  • No myocardial infarction within the past 12 months
  • No uncontrolled congestive heart failure
  • No cardiovascular disorder ≥ grade 3 despite treatment
  • No other malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
  • No significant disease, that in the opinion of the investigator, would preclude study treatment (e.g., active infections, interstitial lung disease, or peripheral neuropathy)
  • No history of significant neurological or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder)
  • No legal incapacity or limited legal capacity that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • More than 30 days since prior participation in another clinical trial
  • No concurrent warfarin, phenprocoumon, phenytoin, or sorivudine

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • Yonsei Cancer Center at Yonsei University Medical Center

    Seoul, 120-752

    Joong B. Ahn, MD, 82-2-2228-8134

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase I/II Study to Determine the Safety and Efficacy of Second-Line Treatment With XELOX Plus Gemcitabine in Irinotecan Pre-Treated Advanced Colorectal Cancer Patients

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with capecitabine and oxaliplatin as second-line therapy and to see how well it works in treating patients with advanced colorectal cancer previously treated with irinotecan.

Read the detailed description

OBJECTIVES:

Primary

  • Define the dose-limiting toxicity and maximum tolerated dose of gemcitabine hydrochloride when administered with capecitabine and oxaliplatin as second-line therapy in patients with advanced colorectal cancer previously treated with irinotecan hydrochloride. (Phase I)
  • Determine the recommended phase II dose of gemcitabine hydrochloride in these patients. (Phase I)
  • Assess overall response rate in patients treated with this regimen. (Phase II)

Secondary

  • Assess the progression-free survival of patients treated with this regimen. (Phase II)
  • Assess the time to treatment failure, duration of response, and time to response in patients treated with this regimen. (Phase II)
  • Assess the overall survival of patients treated with this regimen. (Phase II)
  • Assess the safety of this regimen in these patients. (Phase II)

OUTLINE: This is a multicenter, phase I, dose-escalation study of gemcitabine hydrochloride, followed by a phase II, open-label study.

  • Phase I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, oral capecitabine twice daily on days 1-14, and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days.

Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the maximum tolerated dose (MTD) is determined.

  • Phase II: Patients receive gemcitabine hydrochloride at the MTD determined in phase I and capecitabine and oxaliplatin as in phase I.
Keywords
adenocarcinoma of the colon, recurrent colon cancer, stage III colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

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.

  1. Overall response rate as assessed by RECIST criteria

Secondary outcomes (5)

  1. Progression-free survival

  2. Duration of response

  3. Time to treatment failure

  4. Overall survival

  5. Time to response

Timeline

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

  1. First posted4 Jul 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionAug 2009 (estimated)

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 1/2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00496704
Sponsor's protocol ID
CDR0000549901
Other IDs
YONSEI-YCC-4-20060231
Status last verified
Aug 2009
First submitted
3 Jul 2007
Last updated
21 Aug 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing capecitabine, gemcitabine hydrochloride and oxaliplatin in people with Colorectal Cancer, run by Yonsei University at 1 site in South Korea.

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: status not confirmed, as of the sponsor's last update on 21 Aug 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 South Korea. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Overall response rate as assessed by RECIST criteria. 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 NCT00496704.

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 21 Aug 2009.

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