Phase I Trial of Three-Weekly Docetaxel, Carboplatin and Oral CC-5013 in Patients With Advanced Solid Tumors
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Trial of Three-Weekly Docetaxel, Carboplatin and Oral CC-5013 in Patients With Advanced Solid Tumors
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of lenalidomide when administered with docetaxel
and carboplatin in patients with advanced solid tumors.
Secondary
- Determine the safety and toxic effects of this regimen in these patients.
- Determine, preliminarily, the clinical activity of this regimen in these patients.
OUTLINE: This is an open-label, dose-escalation study of lenalidomide.
Patients receive docetaxel IV over 1 hour followed by carboplatin IV on day 1. Patients also
receive oral lenalidomide once daily on days 1-14. Treatment repeats every 21 days for up to
6 courses in the absence of disease progression or unacceptable toxicity. Patients with
stable or responding disease after completion of 6 courses of treatment may continue
lenalidomide alone once daily on days 1-14. Patients whose disease is stable or responding
after completing 2 or 4 courses and who are unable to tolerate further chemotherapy may
continue lenalidomide alone once daily on days 1-14, at the investigator's discretion.
Treatment with lenalidomide repeats every 21 days in the absence of disease progression or
unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of lenalidomide until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. An additional 6-8 patients are treated at
the MTD.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven solid tumor
- Measurable or evaluable disease
- Refractory to standard treatment
- No prior failure of a docetaxel and carboplatin regimen except in the adjuvant
setting
- History of brain disease allowed, provided the following criteria are met:
- Brain disease previously treated with radiotherapy or surgery
- Asymptomatic with no active brain disease, as documented by CT scan or MRI, for
at least 3 months
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 1.5 mg/dL
- Bilirubin normal
- AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases
are present)
- Alkaline phosphatase ≤ 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 weeks after
completion of study treatment
- No serious medical condition, laboratory abnormality, or psychiatric illness that
would preclude giving informed consent, expose the patient to unacceptable risk, or
affect the interpretation of study data
- No known hypersensitivity to thalidomide
- No history of erythema nodosum, characterized by a desquamating rash, while taking
thalidomide or similar drugs
- No pre-existing peripheral neuropathy ≥ grade 2
- No known hypersensitivity or intolerance to taxanes
- No known HIV positivity
- No known infectious hepatitis, types A, B, or C
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 2 prior chemotherapy regimens
- At least 28 days since prior cancer therapy, including radiotherapy, biologic
therapy, hormonal therapy, chemotherapy, or surgery
- At least 28 days since any other prior investigational drug or therapy
- No prior lenalidomide
- No other concurrent chemotherapy or biologic therapy
- No concurrent radiotherapy
- No concurrent use of any other anticancer agents or treatments
- No prophylactic granulocyte colony-stimulating factors (G-CSF) during the first
course of study treatment
- No concurrent prophylactic antibiotics
- No concurrent treatment with the following medications:
- Systemic corticosteroids (except as prophylaxis for docetaxel administration)
- Estrogens
- Azoles
- Macrolides
- Cyclosporine
- Rifampin
- Phenytoin
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of lenalidomide
Safety Issue:
Yes
Principal Investigator
Tarek M. Mekhail, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Case Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CASE-CCF-7216
NCT ID:
NCT00415116
Start Date:
August 2004
Completion Date:
July 2007
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|
