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
Verified date | December 2017 |
Source | Masonic Cancer Center, University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota |
United States,
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 |
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