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Low Dose Weekly Docetaxel Versus Pemetrexed in Previously Treated Advanced Non-Small-Cell Lung Cancer

NCT ID: NCT01004601

Last Updated: 2009-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-10-31

Brief Summary

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Docetaxel and pemetrexed have been validated for previously treated advanced non-small cell lung cancer (NSCLC); however, tolerability is a concern with the docetaxel (tri-weekly 75 mg/m2 schedule). The investigators conducted this study to compare the efficacy and toxicity of weekly low-dose docetaxel versus tri-weekly pemetrexed for previously treated advanced NSCLC.

Detailed Description

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We have been following a schedule of weekly low dose docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks; 60 mg/m2 accumulated dose for each cycle) at our hospital in an effort to achieve better tolerability. We therefore performed an exploratory study, by statistical analyses, to investigate the efficacy and toxicity of such a low dose docetaxel schedule compared to that of pemetrexed in patients with NSCLC who have failed previous chemotherapy.

Conditions

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Non Small Cell Lung Cancer

Keywords

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pretreated failure advanced stage IIIb/IV NSCLC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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low dose docetaxel

Low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)

Group Type ACTIVE_COMPARATOR

docetaxel

Intervention Type DRUG

patients at one university-affiliated hospital received low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)following failure of previous treatment stage IIIb/IV NSCLC.

Pemetrexed

Pemetrexed (500 mg/m2 every 3 weeks)

Group Type ACTIVE_COMPARATOR

pemetrexed

Intervention Type DRUG

patients at one university-affiliated hospital received pemetrexed (500 mg/m2 every 3 weeks) following failure of previous treatment stage IIIb/IV NSCLC.

Interventions

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docetaxel

patients at one university-affiliated hospital received low dose single docetaxel (30 mg/m2 on days 1 and 8 every 3 weeks)following failure of previous treatment stage IIIb/IV NSCLC.

Intervention Type DRUG

pemetrexed

patients at one university-affiliated hospital received pemetrexed (500 mg/m2 every 3 weeks) following failure of previous treatment stage IIIb/IV NSCLC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* stage IIIb or IV NSCLC
* previous treatment with chemotherapy or tyrosin kinase inhibitor
* performance status less than 2

Exclusion Criteria

* age less 18 years
* pregnancy
* performance status 3-4
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Gung Memorial Hospital

Principal Investigators

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Han-Pin Kuo

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

References

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Hanna N, Shepherd FA, Fossella FV, Pereira JR, De Marinis F, von Pawel J, Gatzemeier U, Tsao TC, Pless M, Muller T, Lim HL, Desch C, Szondy K, Gervais R, Shaharyar, Manegold C, Paul S, Paoletti P, Einhorn L, Bunn PA Jr. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol. 2004 May 1;22(9):1589-97. doi: 10.1200/JCO.2004.08.163.

Reference Type BACKGROUND
PMID: 15117980 (View on PubMed)

Di Maio M, Perrone F, Chiodini P, Gallo C, Camps C, Schuette W, Quoix E, Tsai CM, Gridelli C. Individual patient data meta-analysis of docetaxel administered once every 3 weeks compared with once every week second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol. 2007 Apr 10;25(11):1377-82. doi: 10.1200/JCO.2006.09.8251.

Reference Type BACKGROUND
PMID: 17416857 (View on PubMed)

Schuette W, Nagel S, Blankenburg T, Lautenschlaeger C, Hans K, Schmidt EW, Dittrich I, Schweisfurth H, von Weikersthal LF, Raghavachar A, Reissig A, Serke M. Phase III study of second-line chemotherapy for advanced non-small-cell lung cancer with weekly compared with 3-weekly docetaxel. J Clin Oncol. 2005 Nov 20;23(33):8389-95. doi: 10.1200/JCO.2005.02.3739.

Reference Type BACKGROUND
PMID: 16293869 (View on PubMed)

Kunitoh H, Watanabe K, Onoshi T, Furuse K, Niitani H, Taguchi T. Phase II trial of docetaxel in previously untreated advanced non-small-cell lung cancer: a Japanese cooperative study. J Clin Oncol. 1996 May;14(5):1649-55. doi: 10.1200/JCO.1996.14.5.1649.

Reference Type BACKGROUND
PMID: 8622084 (View on PubMed)

Scagliotti GV, Parikh P, von Pawel J, Biesma B, Vansteenkiste J, Manegold C, Serwatowski P, Gatzemeier U, Digumarti R, Zukin M, Lee JS, Mellemgaard A, Park K, Patil S, Rolski J, Goksel T, de Marinis F, Simms L, Sugarman KP, Gandara D. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol. 2008 Jul 20;26(21):3543-51. doi: 10.1200/JCO.2007.15.0375. Epub 2008 May 27.

Reference Type BACKGROUND
PMID: 18506025 (View on PubMed)

Weiss GJ, Langer C, Rosell R, Hanna N, Shepherd F, Einhorn LH, Nguyen B, Paul S, McAndrews P, Bunn PA Jr, Kelly K. Elderly patients benefit from second-line cytotoxic chemotherapy: a subset analysis of a randomized phase III trial of pemetrexed compared with docetaxel in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2006 Sep 20;24(27):4405-11. doi: 10.1200/JCO.2006.06.7835.

Reference Type BACKGROUND
PMID: 16983108 (View on PubMed)

Chen YM, Shih JF, Perng RP, Tsai CM, Whang-Peng J. A randomized trial of different docetaxel schedules in non-small cell lung cancer patients who failed previous platinum-based chemotherapy. Chest. 2006 Apr;129(4):1031-8. doi: 10.1378/chest.129.4.1031.

Reference Type BACKGROUND
PMID: 16608954 (View on PubMed)

Bria E, Cuppone F, Ciccarese M, Nistico C, Facciolo F, Milella M, Izzo F, Terzoli E, Cognetti F, Giannarelli D. Weekly docetaxel as second line chemotherapy for advanced non-small-cell lung cancer: meta-analysis of randomized trials. Cancer Treat Rev. 2006 Dec;32(8):583-7. doi: 10.1016/j.ctrv.2006.07.003. Epub 2006 Aug 21.

Reference Type BACKGROUND
PMID: 16919884 (View on PubMed)

Other Identifiers

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98-2587B

Identifier Type: -

Identifier Source: org_study_id