S9923 R115777 in Treating Patients With Advanced Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005833
• Other study ID #: CDR0000067847
• Secondary ID: S9923U10CA032102
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: June 12, 2012
• Start date: June 2000
• Est. completion date: July 2006

Study information

• Verified date: June 2012
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have recurrent or advanced colorectal cancer.

Description:

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 thereafter.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• R115777
300mg P.O. BID.

Locations

Country	Name	City	State
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Greenville	Greenville	South Carolina
United States	CCOP - Kansas City	Kansas City	Missouri
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California
United States	University of California Davis Medical Center	Sacramento	California
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Wichita	Wichita	Kansas
United States	Veterans Affairs Medical Center - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Whitehead RP, McCoy S, Macdonald JS, Rivkin SE, Neubauer MA, Dakhil SR, Lenz HJ, Tanaka MS, Abbruzzese JL; Southwest Oncology Group. Phase II trial of R115777 (NSC #70818) in patients with advanced colorectal cancer: a Southwest Oncology Group study. Inve — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed complete and partial response rate to R115777	Confirmed complete and partial response rate to R115777 in pts with measurable, disseminated colorectal cancer and no prior therapy for advanced disease.	Once every 8 weeks until progression	No
Secondary	Time to treatment failure and survival	To assess time to treatment failure and survival in this group of patients.	Once every 8 weeks until progression, then once every 6 months for 2 years, then annually until 3 years from registration	No
Secondary	Frequency & severity of toxicities	To assess the frequency and severity of toxicities associated with this treatment.	Weekly for 8 weeks and then once every 4 weeks until progression	Yes