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Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC

Primary Purpose

Advanced Non-Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Pemetrexed
Pemetrexed plus carboplatin
Sponsored by
Gruppo Oncologico Italiano di Ricerca Clinica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-Small Cell Lung Cancer focused on measuring second line treatment, pemetrexed, carboplatin

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Azienda Ospedaliero-Universitaria Umberto I, Clinica di Oncologia Medica
  • Azienda Ospedaliera Ospedali Riuniti di Bergamo, UO di Oncologia MedicaRecruiting
  • Azienda Istituti Ospitalieri di Cremona, UO di Oncologia MedicaRecruiting
  • Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia MedicaRecruiting
  • Ospedale S. Croce, U.O. di Oncologia MedicaRecruiting
  • Azienda Ospedaliera Careggi, UO di Oncologia MedicaRecruiting
  • EO Ospedali Galliera, SC Oncologia MedicaRecruiting
  • Ospedale Versilia, UO di Oncologia MedicaRecruiting
  • USL 6, Presidio Ospedaliero di Livorno, U.O. di Oncologia MedicaAziendaRecruiting
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Oncologia MedicaRecruiting
  • Istituto Nazionale Tumori, SC di Oncologia 2Recruiting
  • Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed EmatologiaRecruiting
  • AO S. Gerardo, Nuovo Ospedale S. Gerardo-settore A, Oncologia Medica
  • Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia MedicaRecruiting
  • Ospedale Silvestrini, S.C. di Oncologia MedicaRecruiting
  • Arcispedale Santa Maria Nuova, UO di Oncologia MedicaRecruiting
  • Azienda Ospedaliera S. Camillo-Forlanini, U.O. di Oncologia MedicaRecruiting
  • Ospedale SS. Annunziata, UO di Oncologia MedicaRecruiting
  • Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia MedicaRecruiting
  • P.O. Treviglio-Caravaggio, U.O. di Oncologia Medica
  • Policlinico "G. B. Rossi"-Borgo Roma, U.O. di Oncologia Medica ClinicizzataRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Monochemotherapy

Combination chemotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2008
Last Updated
July 31, 2009
Sponsor
Gruppo Oncologico Italiano di Ricerca Clinica
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1. Study Identification

Unique Protocol Identification Number
NCT00786331
Brief Title
Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC
Official Title
Randomized Phase II Study of Pemetrexed Versus Pemetrexed and Carboplatin as Second Line Chemotherapy in Advanced Non-small-cell Lung Cancer (NSCLC).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Gruppo Oncologico Italiano di Ricerca Clinica

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In spite of the superiority of single agent over best supportive care in second-line NSCLC, the prognosis of these patients remains poor with a median survival of 6-7 months, justifying the evaluation of new regimens in this setting. An open question in the second-line treatment of NSCLC remains the possible superiority of combination chemotherapy over single agent, as it has been clearly demonstrated in first-line. Particularly, the addition of platinum to either docetaxel or pemetrexed should be further investigated especially in patients with prior response/stable disease to platinum-based first-line chemotherapy. Pemetrexed has shown anti-tumor activity in combination with other chemotherapy agents, including gemcitabine, vinorelbine, taxanes, cisplatin and carboplatin. In this multicenter, open label, randomized phase II trial, pemetrexed 500 mg/m2 and carboplatin AUC 5 will be administered on day 1 every 3 weeks until progression of disease or for a maximum of 4 courses in the experimental arm. The control arm will be pemetrexed as single agent at 500 mg/m2 on day 1 every 3 weeks until progression of disease or for a maximum of 4 courses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-Small Cell Lung Cancer
Keywords
second line treatment, pemetrexed, carboplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Monochemotherapy
Arm Title
B
Arm Type
Experimental
Arm Description
Combination chemotherapy
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 of a 21 days cycle
Intervention Type
Drug
Intervention Name(s)
Pemetrexed plus carboplatin
Intervention Description
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
Primary Outcome Measure Information:
Title
To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC
Time Frame
36 months
Secondary Outcome Measure Information:
Title
To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone.
Time Frame
3 months
Title
To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone.
Time Frame
36 months
Title
To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone.
Time Frame
3 months
Title
To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luca Boni, MD
Phone
+39 0557947553
Email
bonil@aou-careggi.toscana.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Ardizzoni, MD
Organizational Affiliation
Gruppo Oncologico Italiano di Ricerca Clinica
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria Umberto I, Clinica di Oncologia Medica
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Ospedali Riuniti di Bergamo, UO di Oncologia Medica
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Labianca, MD
Facility Name
Azienda Istituti Ospitalieri di Cremona, UO di Oncologia Medica
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodolfo Passalacqua, MD
Facility Name
Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia Medica
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Merlano, MD
Facility Name
Ospedale S. Croce, U.O. di Oncologia Medica
City
Fano, PU
ZIP/Postal Code
61032
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodolfo Mattioli, MD
Facility Name
Azienda Ospedaliera Careggi, UO di Oncologia Medica
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Di Costanzo, MD
Facility Name
EO Ospedali Galliera, SC Oncologia Medica
City
Genova
ZIP/Postal Code
16128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Decensi, MD
Facility Name
Ospedale Versilia, UO di Oncologia Medica
City
Lido di Camaiore, LU
ZIP/Postal Code
55043
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenico Amoroso, MD
Facility Name
USL 6, Presidio Ospedaliero di Livorno, U.O. di Oncologia MedicaAzienda
City
Livorno
ZIP/Postal Code
57122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Falcone, MD
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Oncologia Medica
City
Meldola, FC
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dino Amadori, MD
Facility Name
Istituto Nazionale Tumori, SC di Oncologia 2
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilio Baietta, MD
Facility Name
Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia
City
Modena
ZIP/Postal Code
41100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fausto Barbieri, MD
Facility Name
AO S. Gerardo, Nuovo Ospedale S. Gerardo-settore A, Oncologia Medica
City
Monza, MI
ZIP/Postal Code
20052
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Bidoli, MD
Facility Name
Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia Medica
City
Parma
ZIP/Postal Code
43100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Ardizzoni, MD
Facility Name
Ospedale Silvestrini, S.C. di Oncologia Medica
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucio Crinò, MD
Facility Name
Arcispedale Santa Maria Nuova, UO di Oncologia Medica
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corrado Boni, MD
Facility Name
Azienda Ospedaliera S. Camillo-Forlanini, U.O. di Oncologia Medica
City
Roma
ZIP/Postal Code
00151
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filippo De Marinis, MD
Facility Name
Ospedale SS. Annunziata, UO di Oncologia Medica
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Contu, MD
Facility Name
Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Libero Ciuffreda, MD
Facility Name
P.O. Treviglio-Caravaggio, U.O. di Oncologia Medica
City
Treviglio, BG
ZIP/Postal Code
24047
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barni Sandro, MD
Facility Name
Policlinico "G. B. Rossi"-Borgo Roma, U.O. di Oncologia Medica Clinicizzata
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Santo, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
27052652
Citation
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.
Results Reference
derived
PubMed Identifier
23109689
Citation
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.
Results Reference
derived

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Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC

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