Know Cancer

forgot password

A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Colorectal Cancer

OBJECTIVES: I. Determine the response rate to R115777 in patients with disseminated
colorectal cancer who have been previously treated for advanced disease. II. Assess the time
to treatment failure and survival of these patients with this treatment regimen. III.
Determine the frequency and severity of toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive oral R115777 twice daily on days
1-21. Treatment continues every 28 days in the absence of disease progression or
unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5-7 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced colorectal
adenocarcinoma Well differentiated OR Moderately well differentiated OR Poorly
differentiated Distant metastases not surgically curable Measurable disease No prior
treatment for disseminated disease No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy:
Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal
(ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0
mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception
Must be able to swallow or receive enteral medications through gastrostomy feeding tube No
intractable nausea or vomiting No other prior malignancy for the past 5 years except
adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the
cervix, or any adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior adjuvant
immunotherapy and recovered No concurrent immunotherapy Chemotherapy: At least 4 weeks
since prior adjuvant chemotherapy and recovered No other concurrent chemotherapy Endocrine
therapy: No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior
radiotherapy and recovered No more than 25% of total area of bone marrow irradiated No
concurrent radiotherapy Surgery: At least 2 weeks since prior surgery and recovered Other:
No concurrent proton pump inhibitors No other concurrent anticancer therapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed complete and partial response rate to R115777

Outcome Description:

Confirmed complete and partial response rate to R115777 in pts with measurable, disseminated colorectal cancer and no prior therapy for advanced disease.

Outcome Time Frame:

Once every 8 weeks until progression

Safety Issue:


Principal Investigator

Robert P. Whitehead, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

July 2006

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
University of California Davis Medical Center Sacramento, California  95817
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Kansas City Kansas City, Missouri  64131
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
CCOP - Greenville Greenville, South Carolina  29615
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
CCOP - Northwest Tacoma, Washington  98405-0986