A Phase II Multicenter, Randomized, Placebo Controlled, Double Blinded Clinical Study of KD018 as a Modulator of Irinotecan Chemotherapy in Patients With Metastatic Colorectal Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Edward Chu, MD
Study ID
NCT00730158
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KD018 — DRUG
    Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
  • Irinotecan — DRUG
    Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
  • Placebo — DRUG
    Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.

Study Details

The proposed plan will investigate the mechanism and efficacy of Chinese herbal medicine as an adjunct to chemotherapy in treatment of patients with metastatic colorectal cancer. Our rationale for the therapeutic use of KD018 is its potential activity in reducing chemotherapy-induced toxicity, especially diarrhea.

Key Dates

Start date
Dec 31, 2008
Status verified
Apr 2019
Primary completion
Jun 30, 2016
Completion
Jun 30, 2018

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    irinotecan+ KD018
  • Experimental: Arm B
    irinotecan + placebo

Primary Outcome Measure

Proportion of Participants With Grade 2-4 Toxicities [ Time Frame: Up to 3 months after start of study treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
Yale University Comprehensive Cancer CenterNew HavenConnecticut06520-
Hillman CancerCentersPittsburghPennsylvania15232-

Find similar trials in New Haven, CT

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Yale University Comprehensive Cancer Center· New Haven, CTHillman CancerCenters· Pittsburgh, PA

Related Studies