Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer

University of Minnesota (UMN)

Status and phase

Terminated

Phase 2

Conditions

Lung Cancer

Treatments

Drug: thalidomide

Procedure: conventional surgery

Drug: carboplatin

Drug: gemcitabine hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00281827

LILLY-X-382 (Other Identifier)

2002LS013

0202M17981 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, 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 tumor cells by blocking blood flow to the tumor. Giving carboplatin and gemcitabine together with thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving carboplatin and gemcitabine together with thalidomide works in treating patients who are undergoing surgery for stage II or stage III non-small cell lung cancer.

Full description

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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