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Colorectal CancerPhase 1/2NCT00524706

Phase I/II Study of SOL for Untreated Metastatic Colorectal Cancer

A Phase 1/2 study testing S-1, oral Leucovorin, Oxaliplatin in people with Colorectal Cancer, run by Shizuoka Cancer Center 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Introduction: S-1 is promising drug which could replace 5-fluorouracil plus l-leucovorin (5-FU/l-LV) in treatment of advanced colorectal cancer. Phase I/II study of S-1 plus Oxaliplatin (SOX) demonstrated its promising activity with acceptable toxicity as first-line chemotherapy in patients with untreated metastatic… Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Colorectal Cancer
What is being tested?
S-1, oral Leucovorin, Oxaliplatin
Type of treatment
Pill or oral medicine
How many people
42 participants
Where
1 siteJapan
Study dates
Aug 2007to Apr 2011
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 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent.
  • Adequate oral intake.
  • Histologically proved adenocarcinoma (colorectal cancer).
  • Unresectable, recurrent and advanced colorectal cancer.
  • At least 4 weeks since prior major surgery
  • Age: 20 - 74 at enrollment.
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  • Performance Status (Eastern Cooperative Oncology Group [ECOG] scale): 0 - 2.
  • No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 or Oxaliplatin containing treatment shall be excluded.
  • Proved presence of measurable lesions within 30 days before enrollment.
  • Patients with the following function of bone marrow, liver and kidney based on the laboratory values measured within 15 days before enrollment.
  • Hemoglobin >_ 9.0g/dL
  • WBC: LLN - 12,000/mm3
  • Absolute granulocyte count >_ 1,500/mm3
  • Platelets >_ 100,000/mm3
  • Total Bilirubin <_ 1.5mg/dL
  • AST(GOT) and ALT(GPT) <_ 100U/L
  • ALP <_ 600U/L
  • Creatinine <_ 1.0mg/dl
  • Expected to survive more than 90 days after enrollment.

Who cannot join

  • Patients who not received S-1 and Oxaliplatin as neoadjuvant or adjuvant chemotherapies before enrollment.
  • Contraindication to S-1, and serious hypersensitivity to oral Leucovorin.
  • No other concurrent investigational therapy.
  • Patients did who not received blood transfusion and hematogenesis stimulating agents (ex. Granulocyte-Colony Stimulating Factor).
  • Serious drug hypersensitivity.
  • Prior history of peripheral neuropathy.
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  • Marked infection or inflammation (ex. patients with a fever of 38.0 degrees or higher).
  • Poorly-controlled diabetes, hypertension or hypercalcemia.
  • Severe (inpatient care is needed) arrhythmia, heart disease or its history.
  • Severe (inpatient care is needed) lung disease (ex. interstitial pneumonia or pulmonary fibrosis).
  • Psychiatric disorder requiring to receive treatment with antipsychotic drug.
  • Fresh bleeding from the gastrointestinal tract.
  • Requiring to drainage massive ascites, pleural effusion retention or pericardial fluid.
  • Extensive bone metastasis.
  • Clinically suspicious brain metastasis or brain metastasis.
  • Diarrhea (watery diarrhea).
  • Simultaneously active double cancer.
  • Pregnancy or nursing female patients and possibility (intent) to bear baby. Male patients with intent to impregnate.
  • Other patients evaluated to be inadequate to participate in the study by (sub) investigators.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

Other trials in Japan

About this study

Official title: Phase I/II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) in Patients With Untreated Metastatic Colorectal Cancer

Introduction:

S-1 is promising drug which could replace 5-fluorouracil plus l-leucovorin (5-FU/l-LV) in treatment of advanced colorectal cancer.

Read more

Phase I/II study of S-1 plus Oxaliplatin (SOX) demonstrated its promising activity with acceptable toxicity as first-line chemotherapy in patients with untreated metastatic colorectal cancer and S-1 showed equivalent possibility to 5-FU/l-LV. On the other hand, phase I/II study of S-1 plus oral Leucovorin (S-1/LV) demonstrated that this regimen had enhanced efficacy in comparison with S-1 alone. From these results, it was expected that S-1/LV plus Oxaliplatin (SOL) would be more effective than SOX.

Therefore, phase I/II study of SOL combination therapy was planned.

Purpose A dose-finding study of S-1/LV plus Oxaliplatin (SOL) was planned to determine the recommended dose (RD), and to assess the response rate (RR) in patients with untreated metastatic colorectal cancer. The primary endpoints of the phase I portion are determination of the RD of SOL, and safety.

The phase II portion of this study was aimed to assess the RR of SOL.

Being tested
S-1, oral Leucovorin, Oxaliplatin
Keywords
S-1, oral fluoropyrimidine, tegafur, Gimeracil, Oteracil Potassium, Leucovorin, Calcium Folinate, Oxaliplatin, L-OHP, colorectal cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • S-1, oral Leucovorin, OxaliplatinDrug

What is being measured

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

  1. Determine the RD of S-1, Leucovorin, and Oxaliplatin in phase I setting

    Measured: During 2 cycles

  2. Evaluate the response rate of S-1, Leucovorin, and Oxaliplatin with recommended dose in phase II

    Measured: During chemotherapy

Secondary outcomes (2)

  1. Phase I - Safety - Pharmacokinetic drug-drug interaction - Response rate - Time to treatment failure (TTF) - Progression free survival (PFS) - Overall survival (OS)

  2. Phase II - Safety - Time to treatment failure (TTF) - Progression free survival (PFS) - Overall survival (OS)

Timeline

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

  1. First posted5 Sep 2007 (estimated)
  2. Study startAug 2007
  3. Study completionApr 2011 (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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00524706
Sponsor's protocol ID
SCC-07-01
Status last verified
Nov 2008
First submitted
4 Sep 2007
Last updated
13 Nov 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing S-1, oral Leucovorin, Oxaliplatin in people with Colorectal Cancer, run by Shizuoka Cancer Center 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?

The sponsor lists 19 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 13 Nov 2008. 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 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?

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?

Determine the RD of S-1, Leucovorin, and Oxaliplatin in phase I setting (time frame: During 2 cycles). 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?

On the ClinicalTrials.gov record for NCT00524706.

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 13 Nov 2008.

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