Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- Determine the complete and partial response rates in patients with stage II or IIIA
non-small cell lung cancer treated with neoadjuvant carboplatin, gemcitabine
hydrochloride, and thalidomide.
Secondary
- Determine, preliminarily, the mechanism of action and activity of thalidomide against
lung cancer.
- Determine the 1-year and 2-year survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the operative mortality of patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients receive carboplatin intravenously (IV) over 30 minutes on day 1, gemcitabine
hydrochloride IV over 30 minutes on days 1 and 8, and oral thalidomide once daily on days
1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity. Within 2-6 weeks after the completion of chemotherapy, patients with
resectable tumors undergo surgical resection.
After completion of study treatment, patients are followed every 3 months for 2 years.
Inclusion Criteria:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC),
including any of the following histologic subtypes:
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell undifferentiated carcinoma
- Stage II or IIIA disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral Computerized Axial Tomography (CT) scan
- No tumor involving the superior sulcus (e.g., Pancoast tumor)
- Karnofsky performance status 70-100%
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 2 mg/dL
- Bilirubin < 2 mg/dL
- Aspartate aminotransferase (AST) < 3 times upper limit of normal
Exclusion Criteria:
- Pregnant or nursing
- No nursing during and for ≥ 4 weeks after completion of study treatment
- Positive pregnancy test
- Fertile female patients must use 2 effective methods of contraception 4 weeks before,
during, and for 4 weeks after completion of study treatment
- Fertile male patients must use effective barrier contraception during and for 4 weeks
after completion of study treatment
- Blood, sperm, or ova donation during study treatment
- Post obstructive pneumonia
- Other serious infection or medical illness that would preclude study participation
- Other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or other malignancy that
is unlikely to affect survival for the next 3 years
- Less than 5 years since prior resection of lung disease
- Prior systemic chemotherapy or radiotherapy for non-small cell lung cancer (NSCLC)
- Other concurrent chemotherapy or radiotherapy
- Concurrent hormonal therapy or immunotherapy
- Other concurrent anticancer therapy
- Other concurrent investigational agents
- Concurrent participation in another clinical study
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Patients Reporting Clinical Response
Outcome Description:
Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable. Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy. Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline. Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions. Stable Disease (SD) = Neither PR or PD.
Outcome Time Frame:
At end of 3 -21 day cycles of treatment
Safety Issue:
No
Principal Investigator
Arkadiusz Dudek, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Food and Drug Administration
Study ID:
2002LS013
NCT ID:
NCT00281827
Start Date:
May 2002
Completion Date:
July 2008
Related Keywords:
- Lung Cancer
- adenocarcinoma of the lung
- squamous cell lung cancer
- large cell lung cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
