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A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Colorectal Cancer

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Trial Information

A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer


Inclusion Criteria:



- Histologically confirmed colorectal adenocarcinoma

- Received prior therapy, at least two regimens, containing a fluoropyrimidine,
oxaliplatin, and irinotecan

- Have at least one measurable tumor, as defined by RECIST

- Must be capable of maintaining a central venous line access

Exclusion Criteria:

- Had previous anti-tumor therapy in the 3 weeks prior to study entry

- Have not recovered from all toxicities (excluding alopecia) from prior therapy to
baseline or ≤grade 1 prior to study entry

- Have another malignancy in the past 3 years except curatively treated non-melanoma
skin cancer or carcinoma in situ of the cervix

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Progression Free Survival

Outcome Description:

The primary endpoint was percentage of progression free survival as defined by the percentage of patients without progressive disease(PD)or death, whichever came first, at 3 months of therapy.

Outcome Time Frame:

From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months.

Safety Issue:

No

Principal Investigator

Henry Xiong, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Center for Cancer and Blood Disorders

Authority:

United States: Food and Drug Administration

Study ID:

TAS109-0403

NCT ID:

NCT00824161

Start Date:

January 2009

Completion Date:

December 2010

Related Keywords:

  • Advanced Colorectal Cancer
  • Colorectal Neoplasms

Name

Location
NYU Cancer Institute New York, New York  10016
The University of Texas M.D. Anderson Cancer Center Houston, Texas  
The Center for Cancer and Blood Disorders Fort Worth, Texas  76104