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CompletedNCT00415116Updated Jul 8, 2011

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

A Phase 1 interventional study of carboplatin and docetaxel in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by The Cleveland Clinic. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-08.

Sponsored by The Cleveland Clinic · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

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Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 14 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Interventions

  • Drugcarboplatin
  • Drugdocetaxel
  • Druglenalidomide
06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose of lenalidomide

  2. Dose-limiting toxicity of lenalidomide

Secondary outcomes

  1. Safety and toxicity

  2. Clinical activity

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00415116
Lead sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI)
First posted
Dec 22, 2006
Start date
Aug 2004
Primary completion
Jul 2007
Completion
Jul 2007
Last update
Jul 8, 2011

Study contacts

Tarek M. Mekhail, MD
study chair · Case Comprehensive Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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