SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver

This study has been withdrawn prior to enrollment.
(No enrollment.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00005030
First received: April 6, 2000
Last updated: October 5, 2012
Last verified: October 2012
  Purpose

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

PURPOSE: Randomized phase I trial to compare the effectiveness of different doses of SCH 66336 before surgery in treating patients who have colorectal cancer that has metastasized to the liver.


Condition Intervention Phase
Colorectal Cancer
Metastatic Cancer
Drug: SCH 66336
Procedure: conventional surgery
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IB Study of Oral Administration of SCH 66336 Preoperatively in Patients With Colorectal Carcinoma Metastatic to the Liver Scheduled for Exploratory Laparotomy and/or Resection

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Enrollment: 0
Study Start Date: June 2000
Study Completion Date: September 2000
Primary Completion Date: September 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCH 66336
Starting dose of preoperative oral SCH 66336 100 mg twice daily for 7-14 days prior to exploratory laparotomy and/or resection of hepatic metastases with surgery between days 8-15.
Drug: SCH 66336
Other Name: lonafarnib
Procedure: conventional surgery
Exploratory laparotomy and/or resection of hepatic metastases. Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization. Other patients undergo surgery on days 8-15.
No Intervention: No Treatment
Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization.

Detailed Description:

OBJECTIVES: I. Determine the biologic activity and safety of preoperative SCH 66336 in patients with colorectal carcinoma metastatic to the liver.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four doses of preoperative SCH 66336 (no treatment, 100 mg, 200 mg, or 300 mg). Patients receive oral SCH 66336 twice daily for 7-14 days prior to exploratory laparotomy and/or resection of hepatic metastases. Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization. Other patients undergo surgery on days 8-15.

PROJECTED ACCRUAL: A total of 40 patients (10 per arm) will be accrued for this study within 10 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed colorectal cancer with radiologically documented liver metastases Meet institutional criteria for exploratory laparotomy and/or resection of hepatic metastasis No central nervous system (CNS) metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: Not specified Hematopoietic: white blood count (WBC) greater than 3,000/mm3 Platelet count greater than 150,000/mm3 Hemoglobin at least 10 g/dL (transfusions and/or epoetin alfa allowed if stable without treatment for at least 1 week) Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 5 times ULN Renal: Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception No poor medical risks because of nonmalignant systemic disease No active uncontrolled infection No intractable vomiting (e.g., grade 2 or higher despite antiemetics) or any medical condition that could preclude taking oral medication and gastrointestinal absorption No AIDS related illness HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered No concurrent immunotherapy Chemotherapy: No more than 2 prior chemotherapy regimens for systemic disease At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy, including oral contraceptives No concurrent systemic corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to greater than 30% of bone marrow Whole pelvic radiation alone is not exclusionary No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery Other: At least 4 weeks since other prior investigational therapy and recovered No prior farnesyl protein transferase inhibitor

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005030

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Steven A. Curley, MD M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00005030     History of Changes
Other Study ID Numbers: CDR0000067553, MDA-ID-99229, SPRI-C98-546, NCI-G00-1713, ID99-229
Study First Received: April 6, 2000
Last Updated: October 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
liver metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014