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| Sponsored by: |
Kimmel Cancer Center (KCC) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003089 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Lung Cancer |
Drug: amifostine trihydrate Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 Start Date: | July 1997 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Pennsylvania | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| Study Chair: | Maria Werner-Wasik, MD | Kimmel Cancer Center (KCC) |
More Information
| Study ID Numbers: | CDR0000065792, TJUH-969139, ALZA-97-019-ii, NCI-V97-1343 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003089 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Thoracic Neoplasms Radiation-Protective Agents Amifostine Antimitotic Agents Carboplatin Carcinoma Respiratory Tract Diseases Lung Neoplasms Paclitaxel |
Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Radiation-Protective Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Respiratory Tract Neoplasms Neoplasms by Histologic Type Amifostine Mitosis Modulators |
Carboplatin Antimitotic Agents Protective Agents Pharmacologic Actions Carcinoma Neoplasms Paclitaxel Lung Diseases Tubulin Modulators Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
