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Docetaxel and Thalidomide as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel
thalidomide
Sponsored by
University of Virginia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Cancer Center

Outcomes

Primary Outcome Measures

Complete and partial response rates

Secondary Outcome Measures

Toxicity
Response duration
Survival
Quality of life

Full Information

First Posted
June 13, 2005
Last Updated
January 29, 2010
Sponsor
University of Virginia
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00114192
Brief Title
Docetaxel and Thalidomide as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title
Phase II Study of Docetaxel and Thalidomide as a Second-Line Treatment for Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Thalidomide may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving docetaxel together with thalidomide may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel together with thalidomide works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
thalidomide
Primary Outcome Measure Information:
Title
Complete and partial response rates
Secondary Outcome Measure Information:
Title
Toxicity
Title
Response duration
Title
Survival
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Gillenwater, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Docetaxel and Thalidomide as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

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