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Colorectal CancerPhase 2NCT00974389

S-1 and Bevacizumab in Treating Patients With Colorectal Cancer That is Recurrent or Cannot Be Removed by Surgery

A Phase 2 study testing bevacizumab and tegafur-gimeracil-oteracil potassium in people with Colorectal Cancer, run by Osaka Medical College at 1 site in Japan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Colorectal Cancer
What is being tested?
bevacizumab and tegafur-gimeracil-oteracil potassium
How many people
40 participants
Where
1 siteJapan
Study dates
Jul 2009to Jun 2010
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal carcinoma
  • Inoperable, locally advanced, or metastatic disease
  • KRAS-mutated
  • Concurrently receiving treatment containing irinotecan and oxaliplatin regimens for unresectable or recurrent colorectal cancer
  • Measurable disease according to RECIST
  • No moderate or severe ascites or pleural effusion requiring treatment
  • No metastasis to the CNS

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • White blood cell count > 3,500/mm³ but < 12,000/mm³
  • Neutrophil count > 1,500/mm³
  • Hemoglobin > 9.0 g/dL
  • Platelet count > 100,000/mm³
  • Total bilirubin < 1.5 mg/dL
  • AST and ALT < 100 U/L (< 200 U/L in patients with liver metastasis)
  • Serum creatinine < 1.2 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • Urine dipstick for proteinuria < 1+
  • INR < 1.5
  • Not pregnant or nursing
  • Able to take capsules orally
  • No active second cancer
  • No active infections (e.g., patients with pyrexia of ≥ 38°C)
  • No serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, poorly controlled diabetes, or hypertension)
  • No electrocardiographic abnormalities with cardiac disorder that would clinically preclude the execution of the study as judged by the investigator
  • No serious drug hypersensitivity or a history of drug allergy
  • No thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
  • No history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
  • No clinically significant traumatic injury within the past 4 weeks
  • No severe mental disorder

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Concurrent low-dose aspirin therapy (< 325 mg/day) allowed
  • More than 4 weeks since prior major surgical procedure or open biopsy
  • No prior therapy radiotherapy
  • No prior therapy with S-1
  • No prior chemotherapy include irinotecan and oxaliplatin as first- or second-line treatment.
  • No concurrent continuous treatment with steroids
  • No concurrent treatment with flucytosine

Trial locations and contacts

1 site in 1 country.

Japan1 site, 1 recruiting

  • Osaka Medical College

    Takatsuki, Osaka, 569-8686

    Hiroya Takiuchi, MD, PhD, 81-72-683-1221

    Recruiting

Other trials in Japan

About this study

Official title: Phase II Study of Combination Chemotherapy With S-1 Plus Avastin in Unresectable or Recurrent Colorectal Cancer After Failure of Prior Chemotherapy, Including Irinotecan and Oxaliplatin Regimens.

RATIONALE: Drugs used in chemotherapy, such as S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving S-1 together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving S-1 together with bevacizumab works as third-line therapy in treating patients with colorectal cancer that is recurrent or that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

  • To evaluate giving S-1 with bevacizumab to see how well it works as third-line therapy in KRAS-mutation patients with unresectable or recurrent colorectal cancer.

OUTLINE: Patients receive oral S-1 twice daily on days 1-28 and bevacizumab IV on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Being tested
bevacizumab, tegafur-gimeracil-oteracil potassium
Keywords
stage III colon cancer, stage III rectal cancer, stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent 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.

  • bevacizumabBiological

  • tegafur-gimeracil-oteracil potassiumDrug

What is being measured

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

  1. Disease-control rate

Secondary outcomes (4)

  1. Response rate

  2. Progression-free survival

  3. Overall survival

  4. Safety

Timeline

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

  1. First posted10 Sep 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJun 2010 (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 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00974389
Sponsor's protocol ID
OSAKA-TRICC0901
Other IDs
CDR0000649021
Status last verified
Sep 2009
First submitted
9 Sep 2009
Last updated
12 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and tegafur-gimeracil-oteracil potassium in people with Colorectal Cancer, run by Osaka Medical College at 1 site in Japan.

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 12 Aug 2013. 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 Japan. 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?

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?

Disease-control rate. 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 NCT00974389.

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 12 Aug 2013.

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