Overview

Consolidation Chemotherapy/Concurrent Chemo-radiotherapy for Inoperable Stage III Non-small Cell Lung Cancer (NSCLC)

Status:
Withdrawn
Trial end date:
2013-07-01
Target enrollment:
0
Participant gender:
All
Summary
This is a pilot phase II study of histology based consolidation chemotherapy in patients with inoperable stage III Non-Small Cell Lung Cancer (NSCLC) following concurrent chemo-radiotherapy. Patients with inoperable stage III NSCLC would be treated with standard concurrent chemo-radiotherapy and subsequently those with non-squamous histology would be offered 4 cycles of consolidation pemetrexed and those with squamous histology 4 cycles of consolidation with gemcitabine.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Syed Jafri
Treatments:
Cisplatin
Etoposide
Etoposide phosphate
Gemcitabine
Pemetrexed
Polystyrene sulfonic acid
Criteria
Inclusion Criteria:

1. Adult patients 18 years and older with histology proven NSCLC with inoperable stage
III A or IIIB disease.

2. Inoperable stage III A defined by multiple and or/bulky N2 mediastinal lymph nodes on
computed tomography (CT) scan such that in opinion of treating investigator, the
patient was not a candidate for surgical resection.

3. N2 disease must be documented by either biopsy, fluorodeoxyglucose positron emission
tomography (PET), and or CT scan if nodes are more than 2 cm.

4. Stage IIIB patients must have N3 or T4 status. N3 status must be documented by
presence of contralateral (to the primary tumor) mediastinal lymph node or
supraclavicular or scalene lymph node proven by either biopsy, fluorodeoxyglucose PET,
or more than 2 cm on CT scan.

5. No prior treatment for lung cancer

6. ECOG Performance status of 0-1.

7. Initiation of consolidation chemotherapy within 4-8 weeks of concurrent
chemo-radiotherapy without progression.

8. Adequate organ function

- leukocytes >3,000/mcL

- absolute neutrophil count >1,500/mcL

- platelets >100,000/mcL

- total bilirubin within normal institutional limits

- AST (SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal

- creatinine within normal institutional limits OR

- creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above
institutional normal

All labs should be obtained within 14 days prior to start of study drug treatment.

9. Ability to give informed consent and willingness to adhere to study protocol.

Exclusion Criteria:

1. Patient who have had prior treatment for lung cancer.

2. Prior history of radiation to chest.

3. Known malignancy other than the current cancer.

4. Uncontrolled intercurrent illness including but not limited to ongoing active
infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable
angina, congestive heart failure, myocardial infarction within last six months or
ventricular arrhythmias requiring medication, psychiatric illness that would impair
patients ability to comply with study requirements.

5. Pregnant or lactating women (any women becoming pregnant during the study will be
withdrawn from the study)

6. Patient with documented or symptoms of peripheral neuropathy.

7. History of allergic reaction to compounds similar to the ones used in this study.

8. Malignant effusions (pleural or pericardial)

9. Superior sulcus (Pancoast) tumors.

10. Any condition that would hamper ability to give informed consent or ability to comply
with study protocol.

11. HIV patients on anti-retroviral therapy are in-eligible to participate in this study
because of potential interaction with the study drugs and increase susceptibility for
infections during course of marrow suppressive chemotherapy and radiotherapy.