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Phase I Study of Preoperative Chemo/Radiation (Concurrent Irinotecan/Cisplatin/RT) Followed by Surgery in Limited Stage Small Cell Lung Cancer (SCLC-LS)

Phase 1
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase I Study of Preoperative Chemo/Radiation (Concurrent Irinotecan/Cisplatin/RT) Followed by Surgery in Limited Stage Small Cell Lung Cancer (SCLC-LS)


- Determine the safety and feasibility of neoadjuvant chemoradiotherapy with irinotecan
and cisplatin followed by surgery in patients with limited stage small cell lung

- Determine the pathologic complete response rate of patients treated with this regimen.

- Correlate the level of vascular endothelial growth factor with treatment response and
disease outcome in patients treated with this regimen.

- Correlate genetic polymorphisms in cytochrome P450 1A1, glutathione S-transferase M1
and P1, myeloperoxidase, and NAD(p)H: quinone oxidoreductase with treatment response
and disease outcome in patients treated with this regimen.

OUTLINE: This is a pilot study.

- Induction chemotherapy: Patients receive cisplatin IV over 1 hour on day 1 and
irinotecan IV over 90 minutes on days 1 and 8.

- Chemoradiotherapy: Beginning on day 21, patients receive chemoradiotherapy comprising
radiotherapy once daily, 5 days a week for 4 weeks and then twice daily for 4 days.
Patients also receive cisplatin IV and irinotecan IV over 30-60 minutes once weekly
concurrently with radiotherapy. Treatment continues in the absence of disease
progression or unacceptable toxicity.

At the completion of chemoradiotherapy, patients are evaluated for surgery. Patients who are
candidates for surgery receive one additional course of cisplatin IV and irinotecan IV.
Patients who are not candidates for surgery receive radiotherapy twice daily for 4 days and
cisplatin IV and irinotecan IV as in chemoradiotherapy.

- Surgery: Approximately 2-4 weeks after the last dose of chemotherapy, patients undergo

Patients are followed every 4 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed small cell lung cancer

- Limited stage disease (clinical stage I-IIIA) and meets the following criteria:

- Confined to 1 hemithorax

- No T4 disease based on malignant pleural effusion

- No N3 disease based on contralateral hilar or supraclavicular involvement

- Contralateral mediastinal (N3) nodes greater than 1.5 cm on CT scan must be
biopsied to rule out pathologic involvement

- Measurable or evaluable disease

- Tumor must be able to be encompassed by limited radiotherapy field without
significantly compromising pulmonary function

- No pleural effusion visible on chest x-ray (regardless of cytology)

- No prior complete tumor resection



- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified


- Absolute granulocyte count at least 1,800/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 mg/dL

- No known Gilbert's disease


- Creatinine no greater than 1.5 mg/dL

- Calcium less than 12.0 mg/dL


- No myocardial infarction within the past 6 months

- No congestive heart failure

- No uncontrolled arrhythmias

- No active unstable angina


- Calculated postoperative FEV_1 at least 800 cc

- No chronic obstructive pulmonary disease with FEV_1 no greater than 1 L or
uncontrolled bronchospasm in the unaffected lung


- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 2 years except curatively treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or any other noninvasive

- No history of seizures

- No history of uncontrolled psychiatric illness that would preclude giving informed
consent or complying with study

- No active or uncontrolled infection

- No uncontrolled diabetes mellitus (random blood sugar at least 250 mg/dL)

- No other concurrent serious medical illness

- HIV negative


Biologic therapy

- Not specified


- No prior irinotecan

- No prior topotecan

Endocrine therapy

- Not specified


- No prior radiotherapy to the chest or other areas containing 30% or more of
marrow-bearing bone


- See Disease Characteristics


- No concurrent phenytoin, phenobarbital, or other antiepileptic prophylactic drugs

- No concurrent amifostine

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven Feigenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2003

Completion Date:

October 2009

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111