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Phase I Trial of Three-Weekly Docetaxel, Carboplatin and Oral CC-5013 in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Trial of Three-Weekly Docetaxel, Carboplatin and Oral CC-5013 in Patients With Advanced Solid Tumors



- Determine the maximum tolerated dose of lenalidomide when administered with docetaxel
and carboplatin in patients with advanced solid tumors.


- 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


- 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

- 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


- 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


- 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:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of lenalidomide

Safety Issue:


Principal Investigator

Tarek M. Mekhail, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2004

Completion Date:

July 2007

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms