Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC

July 31, 2009 updated by: Gruppo Oncologico Italiano di Ricerca Clinica

Randomized Phase II Study of Pemetrexed Versus Pemetrexed and Carboplatin as Second Line Chemotherapy in Advanced Non-small-cell Lung Cancer (NSCLC).

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Ancona, Italy, 60020
        • Active, not recruiting
        • Azienda Ospedaliero-Universitaria Umberto I, Clinica di Oncologia Medica
      • Bergamo, Italy, 24128
        • Recruiting
        • Azienda Ospedaliera Ospedali Riuniti di Bergamo, UO di Oncologia Medica
      • Cremona, Italy, 26100
        • Recruiting
        • Azienda Istituti Ospitalieri di Cremona, UO di Oncologia Medica
      • Cuneo, Italy, 12100
        • Recruiting
        • Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia Medica
      • Fano, PU, Italy, 61032
        • Recruiting
        • Ospedale S. Croce, U.O. di Oncologia Medica
      • Firenze, Italy, 50139
        • Recruiting
        • Azienda Ospedaliera Careggi, UO di Oncologia Medica
      • Genova, Italy, 16128
        • Recruiting
        • EO Ospedali Galliera, SC Oncologia Medica
      • Lido di Camaiore, LU, Italy, 55043
        • Recruiting
        • Ospedale Versilia, UO di Oncologia Medica
      • Livorno, Italy, 57122
        • Recruiting
        • USL 6, Presidio Ospedaliero di Livorno, U.O. di Oncologia MedicaAzienda
      • Meldola, FC, Italy, 47014
        • Recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Oncologia Medica
      • Milano, Italy, 20133
        • Recruiting
        • Istituto Nazionale Tumori, SC di Oncologia 2
        • Principal Investigator:
          • Emilio Baietta, MD
      • Modena, Italy, 41100
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia
      • Monza, MI, Italy, 20052
        • Not yet recruiting
        • AO S. Gerardo, Nuovo Ospedale S. Gerardo-settore A, Oncologia Medica
        • Principal Investigator:
          • Paolo Bidoli, MD
      • Parma, Italy, 43100
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia Medica
      • Perugia, Italy, 06156
        • Recruiting
        • Ospedale Silvestrini, S.C. di Oncologia Medica
        • Principal Investigator:
          • Lucio Crinò, MD
      • Reggio Emilia, Italy, 42100
        • Recruiting
        • Arcispedale Santa Maria Nuova, UO di Oncologia Medica
      • Roma, Italy, 00151
        • Recruiting
        • Azienda Ospedaliera S. Camillo-Forlanini, U.O. di Oncologia Medica
      • Sassari, Italy, 07100
        • Recruiting
        • Ospedale SS. Annunziata, UO di Oncologia Medica
      • Torino, Italy, 10126
        • Recruiting
        • Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica
      • Treviglio, BG, Italy, 24047
        • Not yet recruiting
        • P.O. Treviglio-Caravaggio, U.O. di Oncologia Medica
        • Principal Investigator:
          • Barni Sandro, MD
      • Verona, Italy, 37126
        • Recruiting
        • Policlinico "G. B. Rossi"-Borgo Roma, U.O. di Oncologia Medica Clinicizzata
        • Principal Investigator:
          • Antonio Santo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: A
Monochemotherapy
Drug: Pemetrexed
Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 of a 21 days cycle
EXPERIMENTAL: B
Combination chemotherapy
Drug: Pemetrexed plus carboplatin
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone.
Time Frame: 3 months
3 months
To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone.
Time Frame: 36 months
36 months
To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone.
Time Frame: 3 months
3 months
To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone.
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gruppo Oncologico Italiano di Ricerca Clinica

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrea Ardizzoni, MD, Gruppo Oncologico Italiano di Ricerca Clinica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GOIRC 02/2006
  • EudraCT number 2006-004009-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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