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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Drug/Agent Toxicity by Tissue/Organ, Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Maria Werner-Wasik, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)

Authority:

United States: Federal Government

Study ID:

CDR0000065792

NCT ID:

NCT00003089

Start Date:

July 1997

Completion Date:

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Lung Cancer
  • stage II non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • adenocarcinoma of the lung
  • drug/agent toxicity by tissue/organ
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107