Clinical trial NCT00049296: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
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
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
adult mixed glioma
ovarian sarcoma
posterior urethral cancer
primary central nervous system lymphoma
pulmonary carcinoid tumor
recurrent adenoid cystic carcinoma of the oral cavity
recurrent adult brain tumor
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult primary liver cancer
recurrent adult soft tissue sarcoma
recurrent anal cancer
recurrent basal cell carcinoma of the lip
recurrent bladder cancer
recurrent breast cancer
recurrent colon cancer
recurrent esophageal cancer
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent extrahepatic bile duct cancer
recurrent gallbladder cancer
recurrent gastric cancer
recurrent gastrointestinal carcinoid tumor
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent lymphoepithelioma of the nasopharynx
recurrent lymphoepithelioma of the oropharynx
recurrent mantle cell lymphoma
recurrent melanoma
recurrent metastatic squamous neck cancer with occult primary
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent neuroblastoma
recurrent non-small cell lung cancer
recurrent osteosarcoma
recurrent pancreatic cancer
recurrent rectal cancer
recurrent renal cell cancer
recurrent small cell lung cancer
recurrent small intestine cancer
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent transitional cell cancer of the renal pelvis and ureter
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent urethral cancer
recurrent uterine sarcoma
recurrent verrucous carcinoma of the larynx
recurrent verrucous carcinoma of the oral cavity
refractory multiple myeloma
rhabdoid tumor of the kidney
small intestine adenocarcinoma
small intestine leiomyosarcoma
small intestine lymphoma
stage II esophageal cancer
stage II pancreatic cancer
stage III esophageal cancer
stage III multiple myeloma
stage III pancreatic cancer
stage IV adenoid cystic carcinoma of the oral cavity
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Burkitt lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV anal cancer
stage IV basal cell carcinoma of the lip
stage IV bladder cancer
stage IV breast cancer
stage IV colon cancer
stage IV esophageal cancer
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV gastric cancer
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV lymphoepithelioma of the nasopharynx
stage IV lymphoepithelioma of the oropharynx
stage IV mantle cell lymphoma
stage IV melanoma
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV non-small cell lung cancer
stage IV rectal cancer
stage IV renal cell cancer
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV uterine sarcoma
stage IV verrucous carcinoma of the larynx
stage IV verrucous carcinoma of the oral cavity
unresectable extrahepatic bile duct cancer
unresectable gallbladder cancer
unspecified adult solid tumor, protocol specific
urethral cancer associated with invasive bladder cancer
recurrent salivary gland cancer
stage IV salivary gland cancer
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
stage IV adult soft tissue sarcoma
adult grade III meningioma
adult oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma
stage IV pancreatic cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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.
timeFrame: Weekly courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Scot C. Remick, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.