Lenalidomide, Docetaxel, and Carboplatin in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Case Comprehensive Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00415116

Purpose

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.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: carboplatin Drug: docetaxel Drug: lenalidomide	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Docetaxel Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase I Trial of Three-Weekly Docetaxel, Carboplatin and Oral CC-5013 in Patients With Advanced Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose of lenalidomide [ Designated as safety issue: Yes ]
Dose-limiting toxicity of lenalidomide [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety and toxicity [ Designated as safety issue: Yes ]
Clinical activity [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	August 2004

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415116

Sponsors and Collaborators

Case Comprehensive Cancer Center

Investigators

Study Chair:

Tarek M. Mekhail, MD

Case Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000446092, CASE-CCF-7216
Study First Received:	December 21, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00415116
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Docetaxel
Lenalidomide
Carboplatin

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009