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• Status: Withdrawn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.