Phase II Trial of Pulsed Paclitaxel With Concurrent Thoracic Radiotherapy, and Adjuvant Gemcitabine and Carboplatin in Stage IIIA and IIIB Non-Small Cell Lung Cancer - Full Text View

Purpose

This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer

Condition	Intervention	Phase
Non Small Cell Lung Cancer	Drug: Taxol (paclitaxel) Procedure: Radiotherapy Drug: Carboplatin Drug: Gemcitabine	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Trial of Pulsed Paclitaxel With Concurrent Radiotherapy, and Adjuvant Chemotherapy in Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Leo W. Jenkins Cancer Center:

Primary Outcome Measures:

Tumor response using RECIST criteria [ Time Frame: 12/31/2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Locoregional control [ Time Frame: 12/31/2012 ] [ Designated as safety issue: No ]
Distant failure [ Time Frame: 12/31/2012 ] [ Designated as safety issue: No ]
Progression free survival [ Time Frame: 12/31/2012 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2007
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Intervention Details:

paclitaxel 15mg/m2 Q am on Mon/Wed/Fri

Off cord thoracic radiotherapy 200cGy (total dose 1000cGy). Mon/Wed/Fri: radiotherapy is delivered at least 6 hrs after chemotherapy. Tue/Thurs: radiotherapy is delivered 24 hrs or less from the paclitaxel dose the day before.

Off-cord and off-esophagus concomitant boost radiotherapy 100 cGy (total dose 500 cGy)Mon/Wed/Fri of week 5

Carboplatin AUC 5mg/min/ml, prior to Gemcitabine on Wed of weeks 8 & 9

Gemcitabine 1000 mg/m2 at a fixed dose rate of 10mg/m2/min on Wed during week 8 & 9

Detailed Description:

OBJECTIVES Primary

Overall survival
Tumor response using RECIST criteria

Secondary

Determine the toxicity of the proposed treatment in this patient population.
Progression free survival
Locoregional control
Distant failure

STUDY DESIGN

Description of the Study Phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer.

Rationale for Study Design The proposed doses of gemcitabine, carboplatin, paclitaxel, and thoracic radiation therapy have been previously studied and deemed safe. The design of this study is not to find the maximum tolerated dose (MTD) of these agents, but to study the toxicity and overall survival from this combination.

Outcome Measures Primary Outcome Measures

Overall survival
Tumor response using RECIST criteria

Secondary Outcome Measures

Locoregional control
Distant Failure
Progression free survival

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have: IIIA or IIIB non-small cell lung cancer by radiographic or surgical staging, excluding: superior sulcus tumors, tumors with associated atelectasis or obstructive pneumonitis of the entire lung, and tumors with a malignant pleural effusion.
Patients will be included in the study based on the following criteria:
- Patients must be older than 18 years old.
- Patients must have a Zubrod performance status of 0 to 2
- Patients with adequate bone marrow function
- Patients with adequate renal function
- Patients with adequate hepatic function
- Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.
- Patients who are suitable for treatment with radical intent using concurrent chemotherapy and radiation.
- Patients who have signed an approved informed consent and authorization permitting release of personal health information.

Exclusion Criteria:

Disease-Specific Exclusions
- Superior sulcus tumors
- Atelectasis or obstructive pneumonitis of the entire lung
- Malignant pleural effusion
General Medical Exclusions
- Surgical candidates
- Patients who are pregnant at the time of diagnosis
- Serious concomitant systemic disorders incompatible with the study
- Inability to comply with study and/or follow-up procedures
- Life expectancy of less than 12 weeks
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
- Patients with septicemia or severe infection.
- Patients who have circumstances that will not permit completion of this study or the required follow-up
- Patients with any contraindication to gemcitabine, carboplatin, or paclitaxel

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449657

Contacts

Contact: Paul Walker, MD	252-744-1888	walkerp@ecu.edu
Contact: Susan Eubanks, RN, OCN	252-744-1015	eubankss@ecu.edu

Locations

United States, North Carolina
Brody School of Medicine at East Carolina University	Recruiting
Greenville, North Carolina, United States, 27834

Sponsors and Collaborators

Leo W. Jenkins Cancer Center

Investigators

Principal Investigator:

Paul Walker, MD

Brody School of Medicine at East Carolina University

More Information

Additional Information:

Leo W. Jenkins Cancer Center at Brody School of Medicine at East Carolina University website This link exits the ClinicalTrials.gov site

Publications:

Travis WD, Lubin J, Ries L, Devesa S. United States lung carcinoma incidence trends: declining for most histologic types among males, increasing among females. Cancer. 1996 Jun 15;77(12):2464-70.

Pisani P, Parkin DM, Ferlay J. Estimates of the worldwide mortality from eighteen major cancers in 1985. Implications for prevention and projections of future burden. Int J Cancer. 1993 Dec 2;55(6):891-903.

Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30.

Peto R, Lopez AD, Boreham J, Thun M, Heath C Jr. Mortality from tobacco in developed countries: indirect estimation from national vital statistics. Lancet. 1992 May 23;339(8804):1268-78.

Hoffman PC, Mauer AM, Vokes EE. Lung cancer. Lancet. 2000 Feb 5;355(9202):479-85. Review. Erratum in: Lancet 2000 Apr 8;355(9211): 1280.

Jemal A, Murray T, Samuels A, Ghafoor A, Ward E, Thun MJ. Cancer statistics, 2003. CA Cancer J Clin. 2003 Jan-Feb;53(1):5-26.

Onishi H, Araki T, Shirato H, Nagata Y, Hiraoka M, Gomi K, Yamashita T, Niibe Y, Karasawa K, Hayakawa K, Takai Y, Kimura T, Hirokawa Y, Takeda A, Ouchi A, Hareyama M, Kokubo M, Hara R, Itami J, Yamada K. Stereotactic hypofractionated high-dose irradiation for stage I nonsmall cell lung carcinoma: clinical outcomes in 245 subjects in a Japanese multiinstitutional study. Cancer. 2004 Oct 1;101(7):1623-31.

Chen Y, Pandya K, Keng PC, Johnstone D, Li J, Lee YJ, Smudzin T, Okunieff P. Phase I/II clinical study of pulsed paclitaxel radiosensitization for thoracic malignancy: a therapeutic approach on the basis of preclinical research of human cancer cell lines. Clin Cancer Res. 2003 Mar;9(3):969-75.

Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S Jr, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR; American Society of Clinical Oncology. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol. 2004 Jan 15;22(2):330-53. Epub 2003 Dec 22. Review. No abstract available.

Hotta K, Matsuo K, Ueoka H, Kiura K, Tabata M, Tanimoto M. Meta-analysis of randomized clinical trials comparing Cisplatin to Carboplatin in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2004 Oct 1;22(19):3852-9. Epub 2004 Aug 23.

Zatloukal P, Petruzelka L, Zemanova M, Kolek V, Skrickova J, Pesek M, Fojtu H, Grygarkova I, Sixtova D, Roubec J, Horenkova E, Havel L, Prusa P, Novakova L, Skacel T, Kuta M. Gemcitabine plus cisplatin vs. gemcitabine plus carboplatin in stage IIIb and IV non-small cell lung cancer: a phase III randomized trial. Lung Cancer. 2003 Sep;41(3):321-31.

Bajetta E, Stani SC, De Candis D, Zaffaroni N, Zilembo N, Cortinovis D, Aglione S, Mariani L, Formisano B, Bidoli P. Preclinical and clinical evaluation of four gemcitabine plus carboplatin schedules as front-line treatment for stage IV non-small-cell lung cancer. Ann Oncol. 2003 Feb;14(2):242-7.

Grunewald R, Kantarjian H, Keating MJ, Abbruzzese J, Tarassoff P, Plunkett W. Pharmacologically directed design of the dose rate and schedule of 2',2'-difluorodeoxycytidine (Gemcitabine) administration in leukemia. Cancer Res. 1990 Nov 1;50(21):6823-6.

Abbruzzese JL, Grunewald R, Weeks EA, Gravel D, Adams T, Nowak B, Mineishi S, Tarassoff P, Satterlee W, Raber MN, et al. A phase I clinical, plasma, and cellular pharmacology study of gemcitabine. J Clin Oncol. 1991 Mar;9(3):491-8.

Soo RA, Wang LZ, Tham LS, Yong WP, Boyer M, Lim HL, Lee HS, Millward M, Liang S, Beale P, Lee SC, Goh BC. A multicentre randomised phase II study of carboplatin in combination with gemcitabine at standard rate or fixed dose rate infusion in patients with advanced stage non-small-cell lung cancer. Ann Oncol. 2006 Jul;17(7):1128-33. Epub 2006 May 2.

Responsible Party:	Leo W. Jenkins Cancer Center
ClinicalTrials.gov Identifier:	NCT00449657 History of Changes
Other Study ID Numbers:	LJCC 07-01
Study First Received:	March 16, 2007
Last Updated:	January 3, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Carboplatin
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 18, 2013