NCT00004202

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and RSR13 in treating patients who have stage III non-small cell lung cancer that cannot be removed by surgery.

Trial Health

90
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1998

Geographic Reach
2 countries

16 active sites

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

October 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2000

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

June 25, 2004

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

4.3 years

First QC Date

January 21, 2000

Last Update Submit

August 20, 2021

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer

Interventions

carboplatinDRUG
chemotherapyDRUG
efaproxiralDRUG
paclitaxelDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced unresectable stage IIIA or IIIB non-small cell lung cancer (NSCLC), including: Squamous cell carcinoma OR Adenocarcinoma (including bronchoalveolar cell) OR Large cell anaplastic carcinoma (including giant and clear cell) OR Poorly differentiated NSCLC No small cell carcinoma No distant metastases Measurable or evaluable disease by chest x-ray, CT, or MRI scan Tumors adjacent to vertebral body are eligible if all gross disease is in the radiation boost field No pleural effusion(s) that are exudative, bloody, or cytologically malignant No asymptomatic brain metastases by CT or MRI scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion or epoetin alfa allowed) Hepatic: Bilirubin less than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No uncontrolled serious cardiac disease No active congestive heart failure, unstable angina, pericardial effusion, or arrhythmia Pulmonary: FVC or FEV1 at least 50% Resting or exercise SaO2 on room air at least 90% by pulse oximetry Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active concurrent malignancy within the past 5 years, except: Nonmelanomatous skin cancer Carcinoma in situ of the cervix No serious medical or psychiatric illness that would preclude compliance No active serious infection No concurrent clinically significant peripheral neuropathy No prior significant allergic reaction to drugs containing Cremophor (e.g., cyclosporine or vitamin K) No greater than 10% weight loss in the past 3 months PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy No concurrent immunotherapy (during radiotherapy (RT) and RSR13 administration) Chemotherapy: No prior systemic chemotherapy No concurrent chemotherapy (during RT and RSR13 administration) Endocrine therapy: No concurrent hormonal therapy (during RT and RSR13 administration) Radiotherapy: No prior radiotherapy to the thorax Surgery: At least 1 week since prior diagnostic thoracoscopy OR At least 3 weeks since prior thoracotomy and recovered No prior total surgical resection Other: At least 3 weeks since other prior investigational agents or devices No prior RSR13

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

Sponsors & Collaborators

Study Sites (16)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Cedars-Sinai Comprehensive Cancer Center

Los Angeles, California, 90048, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

Cleveland Clinic Cancer Center

Cleveland, Ohio, 44195, United States

Location

Boston Cancer Group

Memphis, Tennessee, 38119, United States

Location

Dan Rudy Cancer Center

Nashville, Tennessee, 37205, United States

Location

Vanderbilt Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Centre Universitaire de Sante de l'Estrie - Site Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Jewish General Hospital - Montreal

Montreal, Quebec, H3T 1E2, Canada

Location

Notre Dame Hospital

Montreal, Quebec, H4L 2M1, Canada

Location

Related Publications (3)

  • Choy H, Swann S, Nabid A, et al.: Comparison of 5-year survival between RTOG-94-10 and a phase 2 study of induction chemotherapy followed by efaproxiral + radiotherapy in patients with locally advanced NSCLC. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-49, S28-9, 2006.

    BACKGROUND

  • Choy H, Nabid A, Stea B, Scott C, Roa W, Kleinberg L, Ayoub J, Smith C, Souhami L, Hamburg S, Spanos W, Kreisman H, Boyd AP, Cagnoni PJ, Curran WJ. Phase II multicenter study of induction chemotherapy followed by concurrent efaproxiral (RSR13) and thoracic radiotherapy for patients with locally advanced non-small-cell lung cancer. J Clin Oncol. 2005 Sep 1;23(25):5918-28. doi: 10.1200/JCO.2005.08.011.

    PMID: 16135463RESULT

  • Nabid A, Choy H, Stea BD, et al.: Encouraging survival results with RSR13 and concurrent radiation therapy: interim analysis of a phase II study for locally advanced unresectable non-small cell lung cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1236, 2002.

    RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CarboplatinDrug TherapyefaproxiralPaclitaxelRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTherapeuticsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Hak Choy, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2000

First Posted

June 25, 2004

Study Start

October 1, 1998

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations

US(10)CA(6)