Lenalidomide, Docetaxel, and Carboplatin in Treating Patients With Advanced Solid Tumors

NeuroTherapia, Inc.

Status and phase

Completed

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: docetaxel

Drug: lenalidomide

Drug: carboplatin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00415116

P30CA043703 (U.S. NIH Grant/Contract)

CASE-CCF-7216

Details and patient eligibility

About

RATIONALE: Lenalidomide may stop the growth of solid tumors by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with docetaxel and carboplatin may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel and carboplatin in treating patients with advanced solid tumors.

Full description

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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