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A Phase IB Study Of Oral SCH 66336 Preoperatively In Patients With Head And Neck Squamous Cell Cancer

Primary Purpose

Carcinoma, Squamous Cell, Cancer of Head and Neck

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SCH66336
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell

Eligibility Criteria

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

Inclusion Criteria: Histologically-confirmed stage II, III and IV squamous cell carcinoma of the head and neck. Patient's tumor is fully resectable and does not require radiotherapy to the entire buccal mucosa or patients who are to be treated with definitive radiation therapy as long as adequate (>2cm^3) of tissue can be obtained post-therapy with SCH66336. ECOG Performance Status of </= 2 Laboratory values (performed within 14 days prior to administration of SCH 66336): White blood cell count greater than 3.0 x 10^9/L Platelet count greater than or equal to 150 x 10^9/L Hemoglobin greater than or equal to 10 gm/dL (100 gm/L). Patients may have received transfusions and/or erythropoietin to attain this value. However, they must have been stable without treatment for at least one week in order to be eligible. Serum creatinine less than 1.5 times the upper limit of normal. Total bilirubin less than 1.5 times the upper limit of normal. SGOT or SGPT (only one of these tests needs to be performed) less than or equal to 5.0 times upper limit of normal. Able to provide written informed consent. Negative pregnancy test (female patients of childbearing potential only), after signing informed consent and prior to registration. Patients may have received prior investigational therapy but at least 4 weeks must have elapsed with recovery from all toxicities. No more than two prior chemotherapy regimens for systemic disease. Exclusion Criteria: Patients who are poor medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection. Uncontrolled heart disease (symptomatic ischemic heart disease or congestive heart failure, or either of these conditions with a variable medication requirement). Patients with QTc prolongation at baseline. Intractable vomiting (e.g., CTC Grade 2 or higher despite antiemetic medication) or any medical condition which could interfere with taking oral medication and gastrointestinal absorption. Patient has received prior induction chemotherapy. Patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair patient's understanding of the informed consent. Prior therapy with a FPT inhibitor. Patient's life expectancy is less than 6 months. Patient has grade 3 or 4 neurotoxicity from previous anticancer treatment or significant neuropathy from any cause. Patient requires total parenteral nutrition with lipids. Chemotherapy, radiation therapy, biologic therapy, or surgery within four weeks prior to administration of SCH 66336. Nitrosourea or mitomycin C administration within 6 weeks of SCH 66336. Lack of resolution of all toxic manifestations of prior chemotherapy, biologic or radiation therapy. Radiation therapy to greater than 30% of bone marrow as defined in Appendix D. (Whole pelvic radiation alone is not exclusionary.) Known HIV positivity or AIDS-related illness. Pregnancy or lactation. Men or women of childbearing potential who are not using an effective method of contraception. Use of oral contraception or other hormonal modalities by the patient is not permitted.

Sites / Locations

  • The University of Texas M. D. Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 31, 2002
Last Updated
October 29, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00038584
Brief Title
A Phase IB Study Of Oral SCH 66336 Preoperatively In Patients With Head And Neck Squamous Cell Cancer
Official Title
A Phase IB Study of Oral Administration of SCH 66336 Preoperatively in Patients With Head and Neck Squamous Cell Cancer Scheduled for Definitive Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Schering-Plough

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
SCH66336 is a drug that has been designed to block the growth of tumor cells and encourage tumor cell death. This is a randomized study where patients will receive study drug or no drug. Participants in this study are scheduled to have surgery to remove head and neck cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell, Cancer of Head and Neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SCH66336

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically-confirmed stage II, III and IV squamous cell carcinoma of the head and neck. Patient's tumor is fully resectable and does not require radiotherapy to the entire buccal mucosa or patients who are to be treated with definitive radiation therapy as long as adequate (>2cm^3) of tissue can be obtained post-therapy with SCH66336. ECOG Performance Status of </= 2 Laboratory values (performed within 14 days prior to administration of SCH 66336): White blood cell count greater than 3.0 x 10^9/L Platelet count greater than or equal to 150 x 10^9/L Hemoglobin greater than or equal to 10 gm/dL (100 gm/L). Patients may have received transfusions and/or erythropoietin to attain this value. However, they must have been stable without treatment for at least one week in order to be eligible. Serum creatinine less than 1.5 times the upper limit of normal. Total bilirubin less than 1.5 times the upper limit of normal. SGOT or SGPT (only one of these tests needs to be performed) less than or equal to 5.0 times upper limit of normal. Able to provide written informed consent. Negative pregnancy test (female patients of childbearing potential only), after signing informed consent and prior to registration. Patients may have received prior investigational therapy but at least 4 weeks must have elapsed with recovery from all toxicities. No more than two prior chemotherapy regimens for systemic disease. Exclusion Criteria: Patients who are poor medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection. Uncontrolled heart disease (symptomatic ischemic heart disease or congestive heart failure, or either of these conditions with a variable medication requirement). Patients with QTc prolongation at baseline. Intractable vomiting (e.g., CTC Grade 2 or higher despite antiemetic medication) or any medical condition which could interfere with taking oral medication and gastrointestinal absorption. Patient has received prior induction chemotherapy. Patient exhibits confusion, disorientation, or has a history of major psychiatric illness which may impair patient's understanding of the informed consent. Prior therapy with a FPT inhibitor. Patient's life expectancy is less than 6 months. Patient has grade 3 or 4 neurotoxicity from previous anticancer treatment or significant neuropathy from any cause. Patient requires total parenteral nutrition with lipids. Chemotherapy, radiation therapy, biologic therapy, or surgery within four weeks prior to administration of SCH 66336. Nitrosourea or mitomycin C administration within 6 weeks of SCH 66336. Lack of resolution of all toxic manifestations of prior chemotherapy, biologic or radiation therapy. Radiation therapy to greater than 30% of bone marrow as defined in Appendix D. (Whole pelvic radiation alone is not exclusionary.) Known HIV positivity or AIDS-related illness. Pregnancy or lactation. Men or women of childbearing potential who are not using an effective method of contraception. Use of oral contraception or other hormonal modalities by the patient is not permitted.
Facility Information:
Facility Name
The University of Texas M. D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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A Phase IB Study Of Oral SCH 66336 Preoperatively In Patients With Head And Neck Squamous Cell Cancer

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