S9923 R115777 in Treating Patients With Advanced Colorectal Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: R115777

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Southwest Oncology Group
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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. Invest New Drugs. 2006 Jul;24(4):335-41. doi: 10.1007/s10637-005-4345-3.

Study record dates

Study Major Dates

• Study Start: June 1, 2000
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: June 2, 2000
• First Submitted That Met QC Criteria: April 9, 2004
• First Posted (Estimate): April 12, 2004

Study Record Updates

• Last Update Posted (Estimate): June 14, 2012
• Last Update Submitted That Met QC Criteria: June 12, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: adenocarcinoma of the rectum; stage IV rectal cancer; stage IV colon cancer; adenocarcinoma of the colon; recurrent colon cancer; recurrent rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Antineoplastic Agents; Tipifarnib
• Other Study ID Numbers: CDR0000067847; U10CA032102 (U.S. NIH Grant/Contract); S9923 (Other Identifier: SWOG)