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

NCT ID: NCT00281827

Last Updated: 2017-12-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2008-07-31

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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Chemotherapy treatment (carboplatin, gemcitabine and thalidomide) every 21 days for 3 courses.

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)

gemcitabine hydrochloride

Intervention Type: DRUG

Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.

thalidomide

Intervention Type: DRUG

Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg.

conventional surgery

Intervention Type: PROCEDURE

Resection - between 2 and 6 weeks following last dose of chemotherapy.

Interventions

carboplatin

Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)

Intervention Type: DRUG

gemcitabine hydrochloride

Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.

Intervention Type: DRUG

thalidomide

Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg.

Intervention Type: DRUG

conventional surgery

Resection - between 2 and 6 weeks following last dose of chemotherapy.

Intervention Type: PROCEDURE

Other Intervention Names

PARAPLATIN; Gemzar; Thalidomid; Surgery; Resection

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arkadiusz Dudek, MD

Role: STUDY_CHAIR

Masonic Cancer Center, University of Minnesota

Locations

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

LILLY-X-382

Identifier Type: OTHER

Identifier Source: secondary_id

0202M17981

Identifier Type: OTHER

Identifier Source: secondary_id

2002LS013

Identifier Type: -

Identifier Source: org_study_id