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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00281827
• Other study ID #: 2002LS013
• Secondary ID: LILLY-X-3820202M
• Status: Terminated
• Phase: Phase 2
• First received: January 24, 2006
• Last updated: December 3, 2017
• Start date: May 2002
• Est. completion date: July 2008

Study information

• Verified date: December 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: July 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin
Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)
• gemcitabine hydrochloride
Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.
• 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.

Procedure:
• conventional surgery
Resection - between 2 and 6 weeks following last dose of chemotherapy.

Locations

Country	Name	City	State
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Reporting Clinical Response	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.	At end of 3 -21 day cycles of treatment
Secondary	Number of Patients Disease-free at 1 Year	Calculated from date of enrollment to date of recurrence or death, whichever came first	1 year
Secondary	Number of Patients Disease-free at 2 Years	Calculated from date of enrollment to date of recurrence or death, whichever came first	2 Years
Secondary	Number of Patients Alive at 1 Year (Survival)	Participants who were alive at one year from date of enrollment .	12 Months
Secondary	Number of Patients Alive at 2 Years (Survival)	Participants who were alive at 2 years from date of enrollment.	24 Months
Secondary	Number of Patients Alive at 56 Months (End of Study)	Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).	Up to 56 months