NCT00003089

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 19, 2004

Completed
Last Updated

July 10, 2013

Status Verified

May 1, 2006

First QC Date

November 1, 1999

Last Update Submit

July 9, 2013

Conditions

Drug/Agent Toxicity by Tissue/OrganLung Cancer

Keywords

stage II non-small cell lung cancersquamous cell lung cancerlarge cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung canceradenocarcinoma of the lungdrug/agent toxicity by tissue/organ

Interventions

amifostine trihydrateDRUG
carboplatinDRUG
paclitaxelDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsLung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Interventions

AmifostineCarboplatinPaclitaxelRadiotherapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsCoordination ComplexesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesTherapeutics

Study Officials

  • Maria Werner-Wasik, MD

    Sidney Kimmel Cancer Center at Thomas Jefferson University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

February 19, 2004

Study Start

July 1, 1997

Study Completion

February 1, 2004

Last Updated

July 10, 2013

Record last verified: 2006-05

Locations

US(1)