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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00449657
• Other study ID #: LJCC 07-01
• Status: Terminated
• Phase: Phase 2
• First received: March 16, 2007
• Last updated: March 13, 2018
• Start date: February 2007
• Est. completion date: August 22, 2017

Study information

• Verified date: March 2018
• Source: Leo W. Jenkins Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

OBJECTIVES Primary

1. Overall survival

2. Tumor response using RECIST criteria

Secondary

1. Determine the toxicity of the proposed treatment in this patient population.

2. Progression free survival

3. Locoregional control

4. 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

1. Overall survival

2. Tumor response using RECIST criteria

Secondary Outcome Measures

1. Locoregional control

2. Distant Failure

3. Progression free survival

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: August 22, 2017
• Est. primary completion date: August 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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:

1. Disease-Specific Exclusions

• Superior sulcus tumors

• Atelectasis or obstructive pneumonitis of the entire lung

• Malignant pleural effusion

2. 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Taxol (paclitaxel)
paclitaxel 15mg/m2 Q am on Mon/Wed/Fri

Procedure:
• Radiotherapy
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

Drug:
• Carboplatin
Carboplatin AUC 5mg/min/ml, prior to Gemcitabine on Wed of weeks 8 & 9
• Gemcitabine
Gemcitabine 1000 mg/m2 at a fixed dose rate of 10mg/m2/min on Wed during week 8 & 9

Locations

Country	Name	City	State
United States	Brody School of Medicine at East Carolina University	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Leo W. Jenkins Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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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. — View 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. — View Citation

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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. — View 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. Epub 2003 Dec 22. Review. — View 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. — View 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. Epub 2006 May 2. — View 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. — View Citation

Zatloukal P, Petruzelka L, Zemanová M, Kolek V, Skricková J, Pesek M, Fojtu H, Grygárková I, Sixtová D, Roubec J, Horenková E, Havel L, Prusa P, Nováková L, Skácel 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response using RECIST criteria		12/31/2014
Secondary	Locoregional control		12/31/2014
Secondary	Distant failure		12/31/2014
Secondary	Progression free survival		12/31/2014