Back to results

Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

Primary Purpose

Non Small Cell Lung Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Taxol (paclitaxel)

Radiotherapy

Carboplatin

Gemcitabine

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Brody School of Medicine at East Carolina University

Outcomes

Primary Outcome Measures

Tumor response using RECIST criteria

Secondary Outcome Measures

Locoregional control

Distant failure

Progression free survival

Full Information

NCT ID

NCT00449657

First Posted

March 16, 2007

Last Updated

March 13, 2018

Sponsor

Leo W. Jenkins Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00449657

Brief Title

Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

Official Title

Phase II Trial of Pulsed Paclitaxel With Concurrent Radiotherapy,and Adjuvant Chemotherapy in Stage III Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Terminated

Why Stopped

Poor accrual, change in standard of care.

Study Start Date

February 2007 (undefined)

Primary Completion Date

August 22, 2017 (Actual)

Study Completion Date

August 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Leo W. Jenkins Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Taxol (paclitaxel)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Radiotherapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

Tumor response using RECIST criteria

Time Frame

12/31/2014

Secondary Outcome Measure Information:

Title

Locoregional control

Time Frame

12/31/2014

Title

Distant failure

Time Frame

12/31/2014

Title

Progression free survival

Time Frame

12/31/2014

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Walker, MD

Organizational Affiliation

Brody School of Medicine at East Carolina University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brody School of Medicine at East Carolina University

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8640694

Citation

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. doi: 10.1002/(SICI)1097-0142(19960615)77:123.0.CO;2-M.

Results Reference

background

PubMed Identifier

8253525

Citation

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. doi: 10.1002/ijc.2910550604.

Results Reference

background

PubMed Identifier

16514137

Citation

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. doi: 10.3322/canjclin.56.2.106.

Results Reference

background

PubMed Identifier

1349675

Citation

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. doi: 10.1016/0140-6736(92)91600-d.

Results Reference

background

PubMed Identifier

10841143

Citation

Hoffman PC, Mauer AM, Vokes EE. Lung cancer. Lancet. 2000 Feb 5;355(9202):479-85. doi: 10.1016/S0140-6736(00)82038-3. Erratum In: Lancet 2000 Apr 8;355(9211): 1280.

Results Reference

background

PubMed Identifier

12568441

Citation

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. doi: 10.3322/canjclin.53.1.5.

Results Reference

background

PubMed Identifier

15378503

Citation

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. doi: 10.1002/cncr.20539.

Results Reference

background

PubMed Identifier

12631594

Citation

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.

Results Reference

background

PubMed Identifier

14691125

Citation

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. doi: 10.1200/JCO.2004.09.053. Epub 2003 Dec 22. No abstract available.

Results Reference

background

PubMed Identifier

15326195

Citation

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. doi: 10.1200/JCO.2004.02.109. Epub 2004 Aug 23.

Results Reference

background

PubMed Identifier

12928123

Citation

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. doi: 10.1016/s0169-5002(03)00233-2.

Results Reference

background

PubMed Identifier

12562651

Citation

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. doi: 10.1093/annonc/mdg060.

Results Reference

background

PubMed Identifier

2208147

Citation

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.

Results Reference

background

PubMed Identifier

1999720

Citation

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. doi: 10.1200/JCO.1991.9.3.491.

Results Reference

background

PubMed Identifier

16670205

Citation

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. doi: 10.1093/annonc/mdl084. Epub 2006 May 2.

Results Reference

background

PubMed Identifier

24246506

Citation

Zhang J, Gay HA, Russo S, Parent T, Aljumaily R, Walker PR. Phase II study of low-dose paclitaxel with timed thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in unresectable stage III non-small cell lung cancer. Lung Cancer. 2014 Jan;83(1):67-72. doi: 10.1016/j.lungcan.2013.09.007. Epub 2013 Sep 25.

Results Reference

derived

Learn more about this trial

Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

We'll reach out to this number within 24 hrs