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

Primary Purpose

Colorectal Cancer, Metastatic Cancer

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SCH 66336
conventional surgery
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    SCH 66336

    No Treatment

    Arm Description

    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.

    Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization.

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 6, 2000
    Last Updated
    November 13, 2018
    Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005030
    Brief Title
    SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No enrollment.
    Study Start Date
    September 29, 1999 (Actual)
    Primary Completion Date
    September 2000 (Actual)
    Study Completion Date
    September 2000 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    M.D. Anderson Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. 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: 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer, Metastatic Cancer
    Keywords
    stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, liver metastases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SCH 66336
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    No Treatment
    Arm Type
    No Intervention
    Arm Description
    Patients randomized to no treatment may undergo surgery at any time within 15 days of randomization.
    Intervention Type
    Drug
    Intervention Name(s)
    SCH 66336
    Other Intervention Name(s)
    lonafarnib
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional surgery
    Intervention Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Steven A. Curley, MD
    Organizational Affiliation
    M.D. Anderson Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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