Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Metastatic Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Steven A. Curley, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000067553

NCT ID:

NCT00005030

Start Date:

June 2000

Completion Date:

September 2000

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location