Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Completed	Adult	Pharmaceutical / Industry	TJUH-969139 ALZA-97-019-ii, NCI-V97-1343, NCT00003089

Objectives

I.   Determine the toxic effects and antitumor efficacy of paclitaxel plus 
carboplatin in patients with unresectable, intrathoracic non-small cell lung 
cancer (NSCLC).

II.  Integrate concurrent thoracic radiation therapy and weekly low dose 
paclitaxel into treatment of this patient population.

III. Investigate a primary chemoradiotherapy treatment approach in a 
population of patients selected on the basis of performance status regardless 
of degree of weight loss.

IV.  Determine the effect of amifostine on the incidence of treatment 
nonhematologic toxic effects, specifically esophagitis, pneumonitis, and 
radiation dermatitis, in these patients.

Entry Criteria

Disease Characteristics:

Histologically proven non-small cell lung cancer
 Adenocarcinoma
 Squamous cell carcinoma
 Large cell carcinoma
 Undifferentiated carcinoma

Stages II-IIIB
 Medically inoperable stage II and IIIA
 Unresectable stage IIIA and IIIB

Partial resection of stage IIIA or IIIB disease with histologically proven
mediastinal lymph node involvement with microscopic or measurable disease

Ineligible for RTOG 9410 or RTOG 9304

Men with elevated PSA no greater than 10 and no clinical evidence of prostate 
carcinoma are eligible

No pleural effusion large enough to be visible by plain chest radiograph,
unless proven to be benign

Limited metastatic disease (no liver metastases) defined as:
 No more than 3 lung nodules outside the primary tumor suspected to be
  metastatic OR
 No more than 3 sites of suspected metastatic disease seen on bone scan or
  skeletal films OR
 1-3 brain metastases, with plans for whole brain irradiation, with or without
  surgery or radiosurgery OR
 Single adrenal metastases not exceeding 3 cm in size

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified   

Chemotherapy:
 No prior chemotherapy

Endocrine therapy:
 Not specified

Radiotherapy:
 No prior thoracic radiotherapy

Surgery:
 See Disease Characteristics

Patient Characteristics:

Age:
 Adult

Performance status:
 ECOG 0-1 OR
 Karnofsky 70-100%

Life expectancy:
 Not specified

Hematopoietic:
 Absolute neutrophil count greater than 2,000/mm3
 Platelet count greater than 100,000/mm3
 Hemoglobin greater than 8 g/dL

Hepatic:
 Transaminases less than 1.5 times normal
 Bilirubin less than 2.0 mg/dL

Renal:
 Creatinine less than 1.8 mg/dL

Other:
 No concurrent severe medical problems
 Calorie intake of at least 1500 kcal/day 
 No history of active malignancy within one year except:
  Basal cell carcinoma of the skin
  Squamous cell carcinoma of the skin
  Superficial transitional cell carcinoma of the urothelium
  Cervical intraepithelial neoplasia
  Stage I cancer of the endometrium
  Stage I cancer of the upper aerodigestive tract

Expected Enrollment

Approximately 15-35 patients will be accrued for this study.

Outline

This is an open label study.

Patients receive induction therapy comprising paclitaxel IV over 3 hours 
followed by carboplatin IV over 1 hour on days 1 and 21.  Patients then 
undergo radiotherapy beginning on day 42 (or no later than day 63) daily 5 
days a week for 7 weeks.  Patients also receive amifostine IV over 15 minutes 
followed by paclitaxel IV over 3 hours weekly (day 1 each week) concurrently 
for the duration of radiotherapy.  On 2 other days of the week, patients 
receive amifostine alone preceding thoracic radiotherapy.

Patients are followed every 3 months for 1 year and then every 6 months until 
disease progression or death.

Trial Contact Information

Trial Lead Organizations

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Maria Werner-Wasik, MD, Protocol chair		Ph: 215-955-7679; 800-533-3669 Email: maria.werner-wasik@mail.tju.edu

Registry Information
Official Title		A Phase II Trial of Induction Paclitaxel plus Carboplatin Followed by Thoracic Radiation Therapy with Concurrent Weekly Low-Dose Paclitaxel and Twice Weekly Amifostine for Patients with Unresectable Locally Advanced or Partially Resected Non-Small Cell Lung Cancer
Trial Start Date		1997-07-10
Registered in ClinicalTrials.gov		NCT00003089
Date Submitted to PDQ		1997-09-17
Information Last Verified		2006-05-19
NCI Grant/Contract Number		CA10815, CA56036

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