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Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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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



- 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.


- 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:


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:


Principal Investigator

Arkadiusz Dudek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




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



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