Phase II Study on the Use of Molecular Analyses-Based Customized Chemotherapy in Patients With Stage IV/IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer (NSCLC)
Evaluation at study entry will include blood tests, computerized tomography (CT) scans or
other types of scans needed to measure other disease sites. A biopsy of one tumor is
required for tumor analysis. If the patient's cancer has spread to other locations that may
be easier to obtain tissue from and be less invasive, then the biopsy specimen may be
collected from one of several possible locations that may exist within the patient's body.
These possible sites include lung, bone, liver, adrenal glands, lymph nodes, nodules under
the skin, or in cases of brain involvement requiring surgery, brain tissue. Sometimes fluids
build up between the lining of the lung and the lung itself. If this happened to the patient
and their doctor tells them the fluid should be drained, then this fluid may also be a
source of cells we can use to analyze the patients cancer. In very rare cases, other sites
might be identified.
Chemotherapy will consist of the assigned two drugs. Chemotherapy will be repeated every
three or four weeks for at least two times. Patients will then have a CT scan to measure
their tumor's response. Response can be reduction of tumor size, no change of tumor size, or
increased tumor size. Doing CT Scans or other tests after every two cycles of chemotherapy
will assess for response. If we see a favorable response we will continue chemotherapy for
a maximum of two times after the best response we can see in the patient's tumor. If the
patient's tumor grows larger, then we discontinue the study and the patient will discuss
other treatment options with their doctor.
During treatment, a blood specimen will be obtained to check the patient's blood counts at
the beginning and end of study, and prior to administration of every dose of chemotherapy.
Approximately 3 teaspoonfuls (15 mls) of blood will be drawn each time.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best Disease Response After a Maximum of Six Cycles.
Determine the number of participants for each category of response rates (RR) in newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) who are treated with a chemotherapeutic regimen assigned to them on the basis of expression of the genes ribonucleotide reductase subunit 1 (ERCC1) and excision repair cross-complementing group 1 gene (RRM1) expression. Prior to treatment we measured the level of ERCC1 and RRM1 expression in the patients tumor, on the basis of which the patient would be assigned a specific doublet chemotherapy.
Gerold Bepler, MD, PhD
H. Lee Moffitt Cancer Center & Research Institute (now at Karmanos Cancer Institute)
United States: Food and Drug Administration
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