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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Shizuoka Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shizuoka Cancer Center
ClinicalTrials.gov Identifier:
NCT00524706
First received: September 4, 2007
Last updated: November 12, 2008
Last verified: November 2008
  Purpose

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 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.


Condition Intervention Phase
Colorectal Cancer
Drug: S-1, oral Leucovorin, Oxaliplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) in Patients With Untreated Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Shizuoka Cancer Center:

Primary Outcome Measures:
  • Determine the RD of S-1, Leucovorin, and Oxaliplatin in phase I setting [ Time Frame: During 2 cycles ]
  • Evaluate the response rate of S-1, Leucovorin, and Oxaliplatin with recommended dose in phase II [ Time Frame: During chemotherapy ]

Secondary Outcome Measures:
  • Phase I - Safety - Pharmacokinetic drug-drug interaction - Response rate - Time to treatment failure (TTF) - Progression free survival (PFS) - Overall survival (OS)
  • Phase II - Safety - Time to treatment failure (TTF) - Progression free survival (PFS) - Overall survival (OS)

Estimated Enrollment: 42
Study Start Date: August 2007
Estimated Study Completion Date: April 2011
  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524706

Locations
Japan
Shizuoka Cancer Center
Shizuoka, Japan, 411-8777
Sponsors and Collaborators
Shizuoka Cancer Center
Investigators
Principal Investigator: Narikazu Boku, MD Shizuoka Cancer Cener, Division of Gastrointestinal Oncology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00524706     History of Changes
Other Study ID Numbers: SCC-07-01
Study First Received: September 4, 2007
Last Updated: November 12, 2008
Health Authority: Japan: Institutional Review Board

Keywords provided by Shizuoka Cancer Center:
S-1
oral fluoropyrimidine
tegafur
Gimeracil
Oteracil Potassium
Leucovorin
Calcium Folinate
Oxaliplatin
L-OHP
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Levoleucovorin
Oxaliplatin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014