CancerPhase 1NCT00049296
Thalidomide and Docetaxel in Treating Patients With Advanced Cancer
A Phase 1 study testing docetaxel and thalidomide in people with Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- docetaxel and thalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Jan 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel: A Regimen Based on Anti-Angiogenic Therapeutic Principles
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.
Read the 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
- Cancer
- Being tested
- docetaxel, thalidomide
- 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
- Medical subject headings
- Neoplasms, Astrocytoma, Breast Neoplasms, Male, Oligodendroglioma, Choroid Plexus Neoplasms, Craniopharyngioma, Neuroectodermal Tumors, Primitive, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
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.
thalidomideDrug
Also called alpha-phthalimidoglutarimide, N-phthaloylglutamimide, N-phthalylglutamic acid imide
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.
Measured: Weekly courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 2002
- Primary completionDec 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Scot C. Remick, MD, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049296
- Sponsor's protocol ID
- CWRU4Y01
- Other IDs
- P30CA043703, CWRU-4Y01, NCI-G02-2123
- Status last verified
- Jun 2010
- First submitted
- 12 Nov 2002
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18470481
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel: A Regimen Based on Anti-Angiogenic Therapeutic Principles
- ClinicalTrials.gov ID
- NCT00049296
- Acronym / sponsor ID
- CWRU4Y01
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxelPatients 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. | Drug | – |
| thalidomideAlso: alpha-phthalimidoglutarimide, N-phthaloylglutamimide, N-phthalylglutamic acid imidePatients 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. | Drug | – |
Primary outcome
Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.
Time frame: Weekly courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2010.
- Results publication: PubMed 18470481Sanborn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scot C. Remick, MD principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing docetaxel and thalidomide in people with Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma. (time frame: Weekly courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00049296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2010; AzTrials last refreshed its copy on 7 Nov 2026.