Phase I Study of Biweekly SIRB Regimen for Metastatic Colorectal Cancer

NCT03380689 | Withdrawn Phase 1

• 1 other identifier: FNF008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I Study of biweekly combination therapy with S-1, Irinotecan, and Bevacizumab as 1-line Chemotherapy in Patients With Advanced Colorectal Cancer.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerance dose

  Maximum tolerance dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DTL reported.

  From enrollment to completion of study. Estimated about 12 months.

Secondary Outcomes (4)

• Dose limiting toxicity

  From enrollment to completion of study. Estimated about 12 months.

• Objective response rate

  From enrollment to 6 months after treatment.

• Progression-free survival

  From enrollment to progression of disease. Estimated about 6 months.

• Overall survival

  From enrollment to death of patients. Estimated about 1 year.

Study Arms (1)

SIRB2

EXPERIMENTAL

Biweekly combination therapy with S-1, Irinotecan, and Bevacizumab

Drug: S-1; Drug: Irinotecan; Drug: Bevacizumab

Interventions

S-1 DRUG

\- S-1 is administered orally on days 1 to 7 of a 14-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA \<1.25m2), 50 mg (BSA \>1.25 to \<1.50 m2), or 60 mg (BSA \>1.50 m2).

Also known as: S1

SIRB2

Irinotecan DRUG

\- CPT-11 was administrated as a 90-min intravenous infusion on day 1 of a 14-day cycle. Five escalating dose levels of CPT-11 were prepared, at an initial dose of 75mg/m2/day (level 1), stepping up to 100 (level 2), 125 (level 3), 150 (level 4) or 175 (level 5) mg/m2/day.

Also known as: CPT-11

SIRB2

Bevacizumab DRUG

\- Bevacizumab (5 mg/kg) is administered by intravenous infusion over the course of 30 to 90 min on day 1 of each 2-week cycle.

Also known as: Avastin

SIRB2

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
• Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
• Patients with no previous treatment (radiotherapy or chemotherapy). Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment.
• Age ≥20 years
• Life expectancy of at least 3 months
• ECOG PS of 0 or 1
• Adequate function of major organs as defined below:
• Hemoglobin ≥9.0g/dL
• White blood cell count ≥3,500/mm3
• Neutrophil count ≥1,500/mm3
• Platelet count ≥100,000/mm3
• AST and ALT ≤100 U/L (\<200 U/L in patients with liver metastasis)
• Serum creatinine ≤1.2 mg/dL
• Creatinine clearance estimate by the Cockcroft-Gault method \>50 mL/min (reduce initial dosage by one step if ≥50 but \<80 mL/min)
• Able to take capsules orally.

You may not qualify if:

• Serious drug hypersensitivity or a history of drug allergy
• Active double cancer
• Active infections (e.g., patients with pyrexia of 38℃ or higher)
• History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.
• Uncontrolled hypertension
• Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
• Moderate or severe ascites or pleural effusion requiring treatment
• Watery diarrhea
• Treatment with flucytosine or atazanavir sulfate
• Metastasis to the CNS
• Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
• Severe mental disorder
• Continuous treatment with steroids
• Urine dipstick for proteinuria should be \<2+
• Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Rongbo Lin

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

S 1 (combination); Irinotecan; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rongbo Lin, MD

  Fujian Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2017
• First Posted: December 21, 2017
• Study Start: January 5, 2018
• Primary Completion: July 5, 2018
• Study Completion: January 5, 2019
• Last Updated: March 8, 2021

Record last verified: 2017-12

Locations

CN (1)