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Metastatic or Recurrent Colorectal CancerPhase 2NCT01409005

Gemcitabine-UFTE Chemotherapy in Refractory Colorectal Cancer

A Phase 2 study testing Gemcitabine and UFTE chemotherapy in people with Metastatic or Recurrent Colorectal Cancer and Refractory to Fluoropyrimidine, Oxaliplatin and Irinotecan, run by Seoul National University Bundang Hospital at 3 sites in South Korea.

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

Although there have been remarkable advances in the treatment of metastatic or recurrent colorectal cancer (MRCRC), long term survival cannot be expected in most patients with MRCRC because of inevitably developing resistance to chemotherapeutic drugs except some MRCRC patients who can undergo complete resection… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Gemcitabine and UFTE chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
3 sitesSouth Korea
Study dates
Jun 2011to Feb 2013
Phase
Phase 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

Who may be able to join

  • Age: ≥ 18 years old
  • ECOG performance status: 0 to 2
  • Pathologically proven adenocarcinoma of colorectum
  • Patients who had received all cytotoxic drugs of 3 categories (fluoropyrimidine [5-FU, capecitabine or S-1 etc.], oxaliplatin and irinotecan).
  • Refractory MRCRC that progressed while receiving, or within 6 months after the discontinuation of all of fluoropyrimidine, oxaliplatin and irinotecan. When retry of fluoropyrimidine, oxaliplatin or irinotecan is not possible due to previous severe toxicities despite progression-free interval ≥ 6 months, patients can be enrolled into this study.
  • Patients who were previously treated with cetuximab or to whom cetuximab cannot be used (i.e. K-ras mutant or economical problems)
  • At least one measurable lesion should exist (RECIST version 1.1)

Who cannot join

  • Patients who had not previously received all of fluoropyrimidine, oxaliplatin and irinotecan will be excluded.
  • Patients who had received UFTE chemotherapy previously. However, if UFTE chemotherapy was used as adjuvant chemotherapy and the disease-free interval was greater than 6 months, the patient can be included into this study.
  • Patients receiving active or passive immunotherapy
  • Patients with complete bowel obstruction or progressive symptoms of partial bowel obstruction that interfere with adequate oral diet.
  • Patients with large amount of ascites requiring frequent therapeutic paracentesis (> once per week)
  • Pregnant or breast-feeding women (a pregnancy test must be performed on all female patients who are of child-bearing potential before entering the study)
Show all 23Show fewer
  • Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period. Sexually active fertile men not using effective birth control during the study if their partners are women of child-bearing potential
  • Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy (i.e., uncontrolled infection, uncontrolled epilepsy, cerebrovascular accidents within the past 6 months, neurologic or psychological disease interfering with study treatment)
  • Inadequate cardiovascular function:
  • New York Heart Association class III or IV heart disease,
  • Unstable angina or myocardial infarction within the past 6 months,
  • Symptomatic coronary artery disease
  • History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
  • Symptomatic severe interstitial lung disease or pulmonary fibrosis
  • Patients with impaired renal function: Creatinine clearance < 50mL/min (calculated by Cockcroft and Gault formula)
  • Patients with laboratory results as follows;
  • Number of absolute neutrophil counts (ANC) < 1.5 x 10^9/L
  • Number of thrombocytes < 100 x 10^9/L
  • Total bilirubin > 1.5 x upper limit of normal
  • ALAT, ASAT > 3 x upper limit of normal (in the cases with liver metastasis, > ALAT, ASAT > 5 x upper limit of normal)
  • Alkaline phosphatase > 3 x upper limit of normal (in the cases with liver or bone metastasis, > 5 x upper limit of normal)
  • Major surgery within 4 weeks of start of study treatment, without complete recovery
  • Patients who were included to other clinical trials within the past 4 weeks.

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Seoul National University Hospital

    Seoul, Seoul

  • SMG-SNU Boramae Medical Center

    Seoul, Seoul

Other trials in South Korea

About this study

Official title: A Phase II Trial of Gemcitabine Plus UFTE Combination Chemotherapy as Salvage Treatment in Oxaliplatin, Irinotecan and Fluoropyrimidine-Refractory Metastatic Colorectal Cancer

Although there have been remarkable advances in the treatment of metastatic or recurrent colorectal cancer (MRCRC), long term survival cannot be expected in most patients with MRCRC because of inevitably developing resistance to chemotherapeutic drugs except some MRCRC patients who can undergo complete resection (metastasectomy). Until now, approved cytotoxic drugs for treatment of MCRC are only 3 categories (fluoropyrimidine, oxaliplatin and irinotecan). Recently, molecularly targeted drugs are approved for MRCRC patients, and bevacizumab and cetuximab (for K-ras wild type tumors) are available. When cytotoxic and targeted drugs are appropriately combined, about 24 months of overall survival (OS) can be expected in patients with MRCRC. However, when these drugs are all used or patients cannot afford to receive expensive targeted drugs because of economical problems, there is no option for chemotherapy and best supportive care is the only option, although some patients still have good performance status and medical conditions. Therefore, there are unmet needs for additional salvage chemotherapy regimens for patients with oxaliplatin, irinotecan and fluoropyrimidine-refractory MRCRC.

In some previous studies, gemcitabine-based chemotherapy showed some antitumor activities in MRCRC patients. Especially, when combined with fluoropyrimidine, gemcitabine has been shown to exert synergic effects on antitumor activities. On these backgrounds, this phase 2 clinical study was designed. In this study, efficacy and safety of gemcitabine plus UFTE chemotherapy will be evaluated in MRCRC patients.

Being tested
Gemcitabine and UFTE chemotherapy
Medical subject headings
Neoplasm Metastasis, Colorectal Neoplasms

What participants receive

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

  • Gemcitabine and UFTE chemotherapyDrug

    Gemcitabine : 800 mg/m2 mix with 150mL of normal saline (i.v.) over 30 min on Days 1, 8 and 15

    UFTE : 200mg/m2 PO q 8 hr, Days 1~21

    Interval: every 4 weeks

Study groups in NCT01409005
Study groupRoleWhat they receive
Gemcitabine plus UFTEExperimentalGemcitabine plus UFTE chemotherapy (Single arm)
Receives: Drug: Gemcitabine and UFTE chemotherapy

What is being measured

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

  1. 8-weeks progression free survival rate (PFS rate)

    % of patients without tumor prgression at 8 weeks after the initiation of chemotherapy

    Measured: Response evaluation using computed tomography (CT) at 8 weeks after the initiation of chemotherapy

Secondary outcomes (3)

  1. Overall survival (OS)

    OS will be measured until death of patients or study completion. Survival status will be followed up every 3 months if study treatment is completed.

    Measured: OS will be measured until death or study completion, with an expected average of 9 months

  2. Response rate (RR)

    RECIST version 1.1 will be used for response evaluation

    Measured: Response evaluation using CT will be performed every 8 weeks until tumor progression or death

  3. Percentage of Patients with Adverse Events

    Hematologic and non-hematologic toxicities will be evaluated.

    Measured: Overall safety will be monitored on every visit of patients during chemotherapy, with an expected average of 4 months

Timeline

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

  1. First posted3 Aug 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionFeb 2013

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01409005
Sponsor's protocol ID
CRC-SNU-2011-01
Status last verified
Jan 2014
First submitted
29 Jul 2011
Last updated
11 Feb 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine and UFTE chemotherapy in people with Metastatic or Recurrent Colorectal Cancer and Refractory to Fluoropyrimidine, Oxaliplatin and Irinotecan, run by Seoul National University Bundang Hospital at 3 sites 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?

The sponsor lists 7 inclusion and 23 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 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 phase mean?

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?

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?

8-weeks progression free survival rate (PFS rate) (time frame: Response evaluation using computed tomography (CT) at 8 weeks after the initiation of chemotherapy). 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 NCT01409005.

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 Feb 2014.

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