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Phase II Study of Docetaxel and Thalidomide as a Second-Line Treatment for Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Phase II Study of Docetaxel and Thalidomide as a Second-Line Treatment for Non-Small Cell Lung Cancer


OBJECTIVES:

Primary

- Determine the complete and partial response rates in patients with stage III or IV
non-small cell lung cancer treated with docetaxel and thalidomide as second-line
therapy.

Secondary

- Determine the toxicity of this regimen in these patients.

- Determine the response duration and survival of patients treated with this regimen.

- Determine the quality of life of patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive docetaxel IV over 30-60 minutes on days 1, 8, and 15. Patients also receive
oral thalidomide once daily on days -7 to 28 for course 1 and on days 1-28 for all
subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity. Patients with stable or responding disease
after 6 courses of treatment may continue study treatment at the discretion of the
investigator. Patients discontinuing docetaxel due to toxicity may continue treatment with
thalidomide at the discretion of the investigator.

Quality of life is assessed at baseline, before each treatment course, after completion of
study treatment, and then every 3 months thereafter.

After completion of study treatment, patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of
the following stage criteria:

- Stage IIIB (with pleural effusion)

- Stage IIIA or IIIB

- Previously treated and not eligible for surgery or definitive thoracic
radiotherapy

- Stage IV

- Measurable or evaluable disease

- Documented disease progression during or after standard first-line chemotherapy that
may have included taxane

- No untreated brain metastases

- Patients with previously treated brain metastases are eligible provided they
have recovered from prior treatment

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

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

- Hemoglobin ≥ 8.0 g/dL

- Platelet count > 100,000/mm^3

Hepatic

- Bilirubin normal

- SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase
normal OR

- SGOT and/or SGPT normal AND alkaline phosphatase ≤ 4 times ULN AND no ascites

- Albumin > 3.0 g/dL

Renal

- Creatinine < 1.5 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception for 4 weeks before,
during, and for ≥ 4 weeks after completion of study treatment

- No HIV positivity

- No peripheral neuropathy > grade 1

- No other malignancy within the past 5 years except inactive nonmelanoma skin cancer
or carcinoma in situ of the cervix or breast

- No active infections

- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
with polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- No more than 1 prior systemic chemotherapy regimen for locally advanced or metastatic
disease

- Prior neoadjuvant or adjuvant systemic chemotherapy allowed

- At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy

- Not specified

Radiotherapy

- Recovered from prior radiotherapy

Surgery

- Not specified

Other

- No other concurrent investigational agents

- No other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete and partial response rates

Safety Issue:

No

Principal Investigator

Heidi Gillenwater, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia

Authority:

United States: Federal Government

Study ID:

11212

NCT ID:

NCT00114192

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Virginia Cancer CenterCharlottesville, Virginia  22908