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Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC

Information source: Gruppo Oncologico Italiano di Ricerca Clinica
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advanced Non-Small Cell Lung Cancer

Intervention: Pemetrexed (Drug); Pemetrexed plus carboplatin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Gruppo Oncologico Italiano di Ricerca Clinica

Official(s) and/or principal investigator(s):
Andrea Ardizzoni, MD, Principal Investigator, Affiliation: Gruppo Oncologico Italiano di Ricerca Clinica

Overall contact:
Luca Boni, MD, Phone: +39 0557947553, Email: bonil@aou-careggi.toscana.it

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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:

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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Luca Boni, MD, Phone: +39 0557947553, Email: bonil@aou-careggi.toscana.it

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
Roberto Labianca, MD, Principal Investigator

Azienda Istituti Ospitalieri di Cremona, UO di Oncologia Medica, Cremona 26100, Italy; Recruiting
Rodolfo Passalacqua, MD, Principal Investigator

Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia Medica, Cuneo 12100, Italy; Recruiting
Marco Merlano, MD, Principal Investigator

Ospedale S. Croce, U.O. di Oncologia Medica, Fano, PU 61032, Italy; Recruiting
Rodolfo Mattioli, MD, Principal Investigator

Azienda Ospedaliera Careggi, UO di Oncologia Medica, Firenze 50139, Italy; Recruiting
Francesco Di Costanzo, MD, Principal Investigator

EO Ospedali Galliera, SC Oncologia Medica, Genova 16128, Italy; Recruiting
Andrea Decensi, MD, Principal Investigator

Ospedale Versilia, UO di Oncologia Medica, Lido di Camaiore, LU 55043, Italy; Recruiting
Domenico Amoroso, MD, Principal Investigator

USL 6, Presidio Ospedaliero di Livorno, U.O. di Oncologia MedicaAzienda, Livorno 57122, Italy; Recruiting
Alfredo Falcone, MD, Principal Investigator

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Oncologia Medica, Meldola, FC 47014, Italy; Recruiting
Dino Amadori, MD, Principal Investigator

Istituto Nazionale Tumori, SC di Oncologia 2, Milano 20133, Italy; Recruiting
Emilio Baietta, MD, Principal Investigator

Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia, Modena 41100, Italy; Recruiting
Fausto Barbieri, MD, Principal Investigator

AO S. Gerardo, Nuovo Ospedale S. Gerardo-settore A, Oncologia Medica, Monza, MI 20052, Italy; Not yet recruiting
Paolo Bidoli, MD, Principal Investigator

Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia Medica, Parma 43100, Italy; Recruiting
Andrea Ardizzoni, MD, Principal Investigator

Ospedale Silvestrini, S.C. di Oncologia Medica, Perugia 06156, Italy; Recruiting
Lucio Crinò, MD, Principal Investigator

Arcispedale Santa Maria Nuova, UO di Oncologia Medica, Reggio Emilia 42100, Italy; Recruiting
Corrado Boni, MD, Principal Investigator

Azienda Ospedaliera S. Camillo-Forlanini, U.O. di Oncologia Medica, Roma 00151, Italy; Recruiting
Filippo De Marinis, MD, Principal Investigator

Ospedale SS. Annunziata, UO di Oncologia Medica, Sassari 07100, Italy; Recruiting
Antonio Contu, MD, Principal Investigator

Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica, Torino 10126, Italy; Recruiting
Libero Ciuffreda, MD, Principal Investigator

P.O. Treviglio-Caravaggio, U.O. di Oncologia Medica, Treviglio, BG 24047, Italy; Not yet recruiting
Barni Sandro, MD, Principal Investigator

Policlinico "G. B. Rossi"-Borgo Roma, U.O. di Oncologia Medica Clinicizzata, Verona 37126, Italy; Recruiting
Antonio Santo, MD, Principal Investigator

Additional Information

Starting date: July 2007
Last updated: July 31, 2009

Page last updated: August 20, 2015

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