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SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver
This study has been completed.
First Received: April 6, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005030
  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: lonafarnib
Procedure: conventional surgery
Phase I

MedlinePlus related topics: Cancer Colorectal Cancer Surgery
Drug Information available for: Lonafarnib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
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 CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005030

Locations
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Steven A. Curley, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067553, MDA-ID-99229, SPRI-C98-546, NCI-G00-1713
Study First Received: April 6, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005030     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
liver metastases

Study placed in the following topic categories:
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Carcinoma
Rectal Cancer
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

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

ClinicalTrials.gov processed this record on May 07, 2009