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AzTrials

Non Small Cell Lung CancerPhase 2NCT00449657

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

A Phase 2 study testing Taxol (paclitaxel), Radiotherapy and Carboplatin in people with Non Small Cell Lung Cancer, run by Leo W. Jenkins Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Taxol (paclitaxel), Radiotherapy and Carboplatin
Type of treatment
Surgery or procedure
How many people
24 participants
Where
1 siteUnited States
Study dates
Feb 2007to 22 Aug 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • Disease-Specific Exclusions
  • Superior sulcus tumors
  • Atelectasis or obstructive pneumonitis of the entire lung
  • Malignant pleural effusion
  • General Medical Exclusions
  • Surgical candidates
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brody School of Medicine at East Carolina University

    Greenville, North Carolina, 27834

Other trials in United States

About this study

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

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

Read the detailed 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
Being tested
Taxol (paclitaxel), Radiotherapy, Carboplatin, Gemcitabine
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Taxol (paclitaxel)Drug

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

  • RadiotherapyProcedure or surgery

    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

  • CarboplatinDrug

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

  • GemcitabineDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor response using RECIST criteria

    Measured: 12/31/2014

Secondary outcomes (3)

  1. Locoregional control

    Measured: 12/31/2014

  2. Distant failure

    Measured: 12/31/2014

  3. Progression free survival

    Measured: 12/31/2014

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completion22 Aug 2017
  4. Study completion22 Aug 2017

Why it stopped: Poor accrual, change in standard of care.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00449657
Sponsor's protocol ID
LJCC 07-01
Status last verified
Mar 2018
First submitted
16 Mar 2007
Last updated
14 Mar 2018
Results posted
No
Data monitoring committee
No

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

    PubMed 8640694

  • 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.

    PubMed 8253525

  • 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.

    PubMed 16514137

  • 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.

    PubMed 1349675

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

    PubMed 10841143

  • 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.

    PubMed 12568441

  • 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.

    PubMed 15378503

  • 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.

    PubMed 12631594

  • 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.

    PubMed 14691125

  • 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.

    PubMed 15326195

  • 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.

    PubMed 12928123

  • 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.

    PubMed 12562651

  • 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.

    PubMed 2208147

  • 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.

    PubMed 1999720

  • 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.

    PubMed 16670205

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Taxol (paclitaxel), Radiotherapy and Carboplatin in people with Non Small Cell Lung Cancer, run by Leo W. Jenkins Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Poor accrual, change in standard of care.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor response using RECIST criteria (time frame: 12/31/2014). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00449657, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.

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