Non Small Cell Lung Cancer Clinical Trial
Official title:
LCCC 0215: Induction Chemotherapy Using Paclitaxel, Carboplatin, CPT-11 With Pegfilgrastim Support Followed by Conformal Radiotherapy and Paclitaxel/Carboplatin/ZD1839 in Locally Advanced Unresectable Stage IIIA/B Non-Small Cell Carcinoma of the Lung
Patients enrolled on this study will have been diagnosed with non-small cell lung cancer
which cannot be removed by an operation. The standard treatment for this disease is a
combination of chemotherapy and radiation therapy; however, the best way to combine these
treatments is not known. This study will examine if the combination of chemotherapy and
radiotherapy has an increased effect on slowing tumor growth with the addition of a drug
called ZD1839.
In this study, chemotherapy will be given initially (induction therapy) to try to control
the spread of the cancer. Then radiation and chemotherapy will be given together. Receiving
chemotherapy at the same time as radiation treatments can enhance the effect of the
radiation. In this study, patients will receive a drug called ZD1839. In laboratory tests on
cancer cells, ZD1839 has shown an additive effect when used in combination with radiation.
ZD1839 has also been shown to slow or stop growth in tumors.
The purpose of this study is to determine the side effects and effectiveness of using ZD1839
when used with radiation in this treatment regimen (induction chemotherapy followed by
combination chemotherapy, ZD1839, and radiation therapy).
Lung cancer remains the leading cause of cancer-related mortality in the United States. In
2002, approximately 170,000 new cases of lung cancer will be diagnosed, and approximately
160,000 deaths will occur. Eighty percent of cases of lung cancer are of the non-small cell
type, and 30 to 35% will be Stage IIIA/B and are considered potentially curable. The
standard of care in the United States for those patients with unresectable Stage IIIA/B and
a good performance status (PS) is a combination of systemic chemotherapy and thoracic
radiation therapy (TRT). What is not clear in the management of these patients is the
optimal strategy to employ in the combined-modality approach, as well as the optimal
chemotherapy and radiation therapy dose and schedule.
Induction and Concurrent Chemoradiation Therapy for Stage IIIA/B NSCLC The use of combined
modality has become the standard of care in unresectable Stage IIIA/B non-small cell lung
cancer (NSCLC). In the curative approach to this disease, both local control and eradication
of occult micrometastatic disease must be achieved. Combined-modality trials employing
induction chemotherapy have suggested a reduction in the rate of metastatic disease,
suggesting that effectively delivered chemotherapy can eradicate occult micrometastatic
disease. All of the trials cited have shown improved survival for the combined-modality arm.
Combined-modality trials employing concurrent chemoradiation have suggested improved
loco-regional control resulting in improved survival. These data suggest that both induction
and concurrent treatment may be important and may exert their benefit in different manners:
induction therapy with effective chemotherapy reduces the rate of overt metastatic disease,
while concurrent treatment improves local control by enhancing the local effect of TRT. Four
trials to date have been published addressing sequential versus concurrent therapy. In these
trials, concurrent treatment yielded improved survival over the sequential approach. The
value of either induction or consolidation therapy in addition to concurrent chemotherapy is
currently being addressed in randomized Phase III trials.
The study will evaluate the incorporation of ZD1839 with concurrent CP and TCRT to a dose of
74 Gy following 2 cycles of induction CIP. The primary objective will be to define the
toxicity profile of this approach. With amendment 2, patients will no longer receive
maintenance ZD1839. Given the data generated on LCCC 9603 and 2001, this "hybrid" platform
of induction CIP followed by concurrent TCRT (74 Gy) and CP seems appropriate for
incorporation of ZD1839 because of the general tolerance of this therapy in good PS,
unresectable, Stage III NSCLC subjects. Given that esophagitis is the primary toxicity seen
with this approach, stopping rules will be in place for excessive esophageal toxicity.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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