S9923 R115777 in Treating Patients With Advanced Colorectal Cancer

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00005833

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

5.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: R115777	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2000

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: R115777 R115777, 300mg PO BID on Days 1-21. 1 cycle=28 days.	Drug: R115777 300mg P.O. BID. Other Names: NSC-702818

Arm

Intervention/Treatment

Experimental: R115777

R115777, 300mg PO BID on Days 1-21. 1 cycle=28 days.

Drug: R115777

300mg P.O. BID.

Other Names:

NSC-702818

Outcome Measures

Primary Outcome Measures

Confirmed complete and partial response rate to R115777 [Once every 8 weeks until progression]
Confirmed complete and partial response rate to R115777 in pts with measurable, disseminated colorectal cancer and no prior therapy for advanced disease.

Secondary Outcome Measures

Time to treatment failure and survival [Once every 8 weeks until progression, then once every 6 months for 2 years, then annually until 3 years from registration]
To assess time to treatment failure and survival in this group of patients.
Frequency & severity of toxicities [Weekly for 8 weeks and then once every 4 weeks until progression]
To assess the frequency and severity of toxicities associated with this treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC/Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033-0800
2	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California	United States	94553
3	University of California Davis Medical Center	Sacramento	California	United States	95817
4	CCOP - Central Illinois	Decatur	Illinois	United States	62526
5	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
6	Veterans Affairs Medical Center - Wichita	Wichita	Kansas	United States	67218
7	CCOP - Kansas City	Kansas City	Missouri	United States	64131
8	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
9	CCOP - Columbus	Columbus	Ohio	United States	43206
10	CCOP - Greenville	Greenville	South Carolina	United States	29615
11	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
12	CCOP - Northwest	Tacoma	Washington	United States	98405-0986