Thalidomide and Docetaxel in Treating Patients With Advanced Cancer
Official Title
Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel: A Regimen Based on Anti-Angiogenic Therapeutic Principles
Acronym
Not provided
Organization
Case Comprehensive Cancer CenterOTHER
Status Module
Record Verification Date
Jun 2010
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2002
Primary Completion Date
Dec 2004Actual
Completion Date
Jan 2006Actual
First Submitted Date
Nov 12, 2002
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 10, 2010
Last Update Posted Date
Jun 11, 2010Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Case Comprehensive Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining thalidomide with docetaxel may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining thalidomide with docetaxel in treating patients who have advanced cancer.
Detailed Description
OBJECTIVES:
Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.
Determine the dose-limiting toxicity and safety profile of this regimen in these patients.
Determine the plasma pharmacokinetics of this regimen in these patients.
Determine the objective tumor response and prolonged freedom from progression in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive oral thalidomide twice daily and docetaxel IV over 30 minutes once weekly. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
Conditions Module
Conditions
Cancer
Keywords
adult anaplastic astrocytoma
male breast cancer
adult anaplastic oligodendroglioma
adult meningeal hemangiopericytoma
adult brain stem glioma
adult central nervous system germ cell tumor
adult choroid plexus tumor
adult craniopharyngioma
adult ependymoblastoma
adult glioblastoma
adult pilocytic astrocytoma
adult anaplastic ependymoma
adult medulloblastoma
adult meningioma
adult pineoblastoma
adult pineocytoma
adult subependymoma
adult myxopapillary ependymoma
advanced adult primary liver cancer
anterior urethral cancer
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
26Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
docetaxel
Drug
Patients receive docetaxel IV over 30 minutes once weekly. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined.
thalidomide
Drug
Patients receive oral thalidomide twice daily. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined.
alpha-phthalimidoglutarimide
N-phthaloylglutamimide
N-phthalylglutamic acid imide
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.
Weekly courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy not amenable to curative surgery, radiotherapy, or chemotherapy
Tumor types may include any of the following:
Any solid tumor including, but not limited to, head and neck, breast, lung, gastrointestinal, genitourinary, melanoma, and sarcoma
Primary CNS neoplasms if the following are true:
Received primary radiotherapy
No concurrent corticosteroids or has been on a stable corticosteroid dose for at least 30 days
No concurrent enzyme-inducible anti-epileptic medications (i.e., carbamazepine or phenytoin)
Multiple myeloma
Non-Hodgkin's lymphoma
No refractory or relapsed acute or chronic leukemia
Measurable or evaluable disease
No life-prolonging therapy available
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age
18 and over
Sex
Male or female
Menopausal status
Not specified
Performance status
ECOG 0-1
Life expectancy
At least 4 months
Hematopoietic
WBC at least 4,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10 g/dL
Hepatic
Bilirubin no greater than upper limit of normal (ULN)
AST and/or ALT no greater than 2.5 times ULN if alkaline phosphatase less than ULN OR
Alkaline phosphatase no greater than 4 times ULN if AST/ALT less than ULN
Renal
Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min
Cardiovascular
No New York Heart Association class III or IV heart disease
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and 4 weeks after study
Willing and able to comply with FDA-mandated STEPS program
No peripheral neuropathy grade 2 or greater
No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
No more than 2 prior courses of mitomycin
Endocrine therapy
See Disease Characteristics
Radiotherapy
At least 4 weeks since prior large-field radiotherapy and recovered
Surgery
Not specified
Other
At least 3 weeks since other prior anticancer therapy and recovered
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Scot C. Remick, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Sanborn SL, Cooney MM, Dowlati A, Brell JM, Krishnamurthi S, Gibbons J, Bokar JA, Nock C, Ness A, Remick SC. Phase I trial of docetaxel and thalidomide: a regimen based on metronomic therapeutic principles. Invest New Drugs. 2008 Aug;26(4):355-62. doi: 10.1007/s10637-008-9137-0. Epub 2008 May 10.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009369
Neoplasms
D001254
Astrocytoma
D018567
Breast Neoplasms, Male
D009837
Oligodendroglioma
D016545
Choroid Plexus Neoplasms
D003397
Craniopharyngioma
D018242
Neuroectodermal Tumors, Primitive
D005909
Glioblastoma
D004806
Ependymoma
D008527
Medulloblastoma
D008579
Meningioma
D010871
Pinealoma
D018315
Glioma, Subependymal
D001063
Appendiceal Neoplasms
D002813
Chondrosarcoma
C554498
AIDS-related Kaposi sarcoma
D012514
Sarcoma, Kaposi
D046152
Gastrointestinal Stromal Tumors
Ancestor Terms
ID
Term
D018302
Neoplasms, Neuroepithelial
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009370
Neoplasms by Histologic Type
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D000077143
Docetaxel
D013792
Thalidomide
Ancestor Terms
ID
Term
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
Browse Leaves
Not provided
Browse Branches
Not provided
carcinoma of the appendix
chondrosarcoma
classic Kaposi sarcoma
AIDS-related Kaposi sarcoma
immunosuppressive treatment related Kaposi sarcoma
recurrent Kaposi sarcoma
clear cell sarcoma of the kidney
disseminated neuroblastoma
extensive stage small cell lung cancer
gastrointestinal stromal tumor
metastatic gastrointestinal carcinoid tumor
metastatic osteosarcoma
metastatic transitional cell cancer of the renal pelvis and ureter