Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug/Agent Toxicity by Tissue/Organ; Lung Cancer
Intervention: amifostine trihydrate (Drug); carboplatin (Drug); paclitaxel (Drug); radiation therapy (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: Kimmel Cancer Center (KCC) Official(s) and/or principal investigator(s):
Maria Werner-Wasik, MD, Study Chair, Affiliation: Kimmel Cancer Center (KCC)
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells
from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage
tumor cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel, carboplatin, amifostine,
and radiation therapy in treating patients who have unresectable locally advanced or
partially resected non-small cell lung cancer.
Clinical Details
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
Study design: Treatment
Detailed description:
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.
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.
PROJECTED ACCRUAL: Approximately 15-35 patients will be accrued for this study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
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
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic radiotherapy
Surgery: See Disease Characteristics
Locations and Contacts
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107-5541, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 1997
Last updated: June 17, 2008
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