NCT00786331

Brief Summary

The aim of this study is to compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

21 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 3, 2009

Status Verified

July 1, 2009

Enrollment Period

2 years

First QC Date

July 1, 2008

Last Update Submit

July 31, 2009

Conditions

Advanced Non-Small Cell Lung Cancer

Keywords

second line treatmentpemetrexedcarboplatin

Outcome Measures

Primary Outcomes (1)

  • To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC

    36 months

Secondary Outcomes (4)

  • To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone.

    3 months

  • To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone.

    36 months

  • To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone.

    3 months

  • To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone.

    36 months

Study Arms (2)

A

ACTIVE COMPARATOR

Monochemotherapy

Drug: Pemetrexed

B

EXPERIMENTAL

Combination chemotherapy

Drug: Pemetrexed plus carboplatin

Interventions

PemetrexedDRUG

Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 of a 21 days cycle

A
Pemetrexed plus carboplatinDRUG

Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 and Carboplatin AUC 5 i.v. over approximately 30 minutes on day 1 (beginning approximately 30 minutes after the end of the pemetrexed infusion) of a 21 days cycle

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent
  • Histologically or cytologically confirmed non-small-cell lung cancer
  • Unresectable stage IIIB, stage IV and unresectable local relapse or metastatic disease, with evidence of disease progression after first line chemotherapy which should have included a platinum agent.
  • ECOG performance status lower than or equal to 2
  • Adequate hematological, hepatic and renal functions
  • Life expectancy greater than or equal to 12 weeks
  • Prior treatment with only 1 chemotherapy regimen for the treatment of advanced disease which should have included a platinum agent
  • At baseline, presence of at least one measurable target lesion as per RECIST criteria

You may not qualify if:

  • Prior treatment with pemetrexed.
  • Patients who are pregnant or lactating
  • Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled.
  • Symptomatic brain metastases
  • History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Concomitant treatment with any other anticancer drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Azienda Ospedaliero-Universitaria Umberto I, Clinica di Oncologia Medica

Ancona, 60020, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliera Ospedali Riuniti di Bergamo, UO di Oncologia Medica

Bergamo, 24128, Italy

RECRUITING

Azienda Istituti Ospitalieri di Cremona, UO di Oncologia Medica

Cremona, 26100, Italy

RECRUITING

Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia Medica

Cuneo, 12100, Italy

RECRUITING

Ospedale S. Croce, U.O. di Oncologia Medica

Fano, PU, 61032, Italy

RECRUITING

Azienda Ospedaliera Careggi, UO di Oncologia Medica

Florence, 50139, Italy

RECRUITING

EO Ospedali Galliera, SC Oncologia Medica

Genova, 16128, Italy

RECRUITING

Ospedale Versilia, UO di Oncologia Medica

Lido Di Camaiore, LU, 55043, Italy

RECRUITING

USL 6, Presidio Ospedaliero di Livorno, U.O. di Oncologia MedicaAzienda

Livorno, 57122, Italy

RECRUITING

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Oncologia Medica

Meldola, FC, 47014, Italy

RECRUITING

Istituto Nazionale Tumori, SC di Oncologia 2

Milan, 20133, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia

Modena, 41100, Italy

RECRUITING

AO S. Gerardo, Nuovo Ospedale S. Gerardo-settore A, Oncologia Medica

Monza, MI, 20052, Italy

NOT YET RECRUITING

Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia Medica

Parma, 43100, Italy

RECRUITING

Ospedale Silvestrini, S.C. di Oncologia Medica

Perugia, 06156, Italy

RECRUITING

Arcispedale Santa Maria Nuova, UO di Oncologia Medica

Reggio Emilia, 42100, Italy

RECRUITING

Azienda Ospedaliera S. Camillo-Forlanini, U.O. di Oncologia Medica

Roma, 00151, Italy

RECRUITING

Ospedale SS. Annunziata, UO di Oncologia Medica

Sassari, 07100, Italy

RECRUITING

Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica

Torino, 10126, Italy

RECRUITING

P.O. Treviglio-Caravaggio, U.O. di Oncologia Medica

Treviglio, BG, 24047, Italy

NOT YET RECRUITING

Policlinico "G. B. Rossi"-Borgo Roma, U.O. di Oncologia Medica Clinicizzata

Verona, 37126, Italy

RECRUITING

Related Publications (2)

  • van Kruijsdijk RC, Visseren FL, Boni L, Groen HJ, Dingemans AM, Aerts JG, van der Graaf Y, Ardizzoni A, Smit EF. Pemetrexed plus carboplatin versus pemetrexed in pretreated patients with advanced non-squamous non-small-cell lung cancer: treating the right patients based on individualized treatment effect prediction. Ann Oncol. 2016 Jul;27(7):1280-6. doi: 10.1093/annonc/mdw154. Epub 2016 Apr 6.

    PMID: 27052652DERIVED

  • Ardizzoni A, Tiseo M, Boni L, Vincent AD, Passalacqua R, Buti S, Amoroso D, Camerini A, Labianca R, Genestreti G, Boni C, Ciuffreda L, Di Costanzo F, de Marinis F, Crino L, Santo A, Pazzola A, Barbieri F, Zilembo N, Colantonio I, Tibaldi C, Mattioli R, Cafferata MA, Camisa R, Smit EF. Pemetrexed versus pemetrexed and carboplatin as second-line chemotherapy in advanced non-small-cell lung cancer: results of the GOIRC 02-2006 randomized phase II study and pooled analysis with the NVALT7 trial. J Clin Oncol. 2012 Dec 20;30(36):4501-7. doi: 10.1200/JCO.2012.43.6758. Epub 2012 Oct 29.

    PMID: 23109689DERIVED

MeSH Terms

Interventions

PemetrexedCarboplatin

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicCoordination ComplexesOrganic Chemicals

Study Officials

  • Andrea Ardizzoni, MD

    Gruppo Oncologico Italiano di Ricerca Clinica

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Boni, MD

CONTACT

+39 0557947553bonil@aou-careggi.toscana.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2008

First Posted

November 6, 2008

Study Start

July 1, 2007

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

August 3, 2009

Record last verified: 2009-07

Locations

IT(21)