Clinical trial NCT00281827: Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer
Official title: Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: 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
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2006-01-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Reporting Clinical Response
timeFrame: At end of 3 -21 day cycles of treatment
Secondary outcomes:
measure: Number of Patients Disease-free at 1 Year
timeFrame: 1 year
measure: Number of Patients Disease-free at 2 Years
timeFrame: 2 Years
measure: Number of Patients Alive at 1 Year (Survival)
timeFrame: 12 Months
measure: Number of Patients Alive at 2 Years (Survival)
timeFrame: 24 Months
measure: Number of Patients Alive at 56 Months (End of Study)
timeFrame: Up to 56 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Robbinsdale
country: United States
facility: Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
state: Minnesota
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Arkadiusz Dudek, MD
role: STUDY_CHAIR
References: