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Phase I Trial of Daily Lenalidomide (CC-5013, Revlimid™) and Docetaxel Given Every Three Weeks in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Trial of Daily Lenalidomide (CC-5013, Revlimid™) and Docetaxel Given Every Three Weeks in Patients With Advanced Solid Tumors


OBJECTIVES:

Primary

- Determine the dose-limiting toxicity and maximum tolerated dose of lenalidomide when
given in combination with docetaxel in patients with advanced solid tumors.

Secondary

- Determine the safety of this regimen in these patients.

- Determine the objective tumor response in patients treated with this regimen.

- Determine the time to progression in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of lenalidomide.

Patients receive oral lenalidomide on days 1-14 and docetaxel IV over 1 hour on day 1.
Courses repeat every 21 days until 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 6
patients experience dose limiting toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed solid tumor

- Advanced disease

- Refractory to standard therapy OR no standard therapy exists

- Measurable or evaluable disease

- No active brain metastases

- Previously treated (e.g., surgery or radiotherapy) brain metastases are allowed
provided they are currently asymptomatic and inactive by CT scan or MRI

PATIENT CHARACTERISTICS:

Performance status

- ECOG 0-2

Life expectancy

- At least 4 months

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8 g/dL

Hepatic

- Bilirubin normal

- Meets 1 of the following criteria:

- Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal
(ULN)

- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

- AP ≤ 5 times ULN AND AST or ALT normal

Renal

- Creatinine ≤ 2 mg/dL

Cardiovascular

- No New York Heart Association class III or IV heart disease

Immunologic

- No prior desquamating rash or ≥ grade 2 allergic reaction while receiving thalidomide

- No history of hypersensitivity to docetaxel or other drugs formulated in polysorbate
80

- No history of allergic reaction to compounds of similar chemical or biologic
composition to study drugs

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other uncontrolled illness or other condition that would preclude study compliance

- No peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent hematopoietic growth factors during course 1 of study treatment

- No concurrent immunotherapy

Chemotherapy

- At least 6 weeks since prior mitomycin or nitrosoureas

- No more than 2 prior courses of mitomycin

- No other concurrent chemotherapy

Radiotherapy

- No prior pelvic radiotherapy

Other

- At least 4 weeks since prior anticancer therapy

- No concurrent warfarin for anticoagulation (heparin is allowed)

- Recovered from all prior treatment

- No other concurrent anticancer therapy except bisphosphonates

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

measured at end of phase I

Safety Issue:

Yes

Principal Investigator

Matthew M. Cooney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE2Y04

NCT ID:

NCT00253344

Start Date:

June 2005

Completion Date:

June 2008

Related Keywords:

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

Name

Location

Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065