Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC
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ClinicalTrials.gov Identifier: NCT00786331 |
Recruitment Status : Unknown
Verified July 2009 by Gruppo Oncologico Italiano di Ricerca Clinica.
Recruitment status was: Recruiting
First Posted : November 6, 2008
Last Update Posted : August 3, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Non-Small Cell Lung Cancer | Drug: Pemetrexed Drug: Pemetrexed plus carboplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 230 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | July 2007 |
Estimated Primary Completion Date : | July 2009 |
Estimated Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
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 |
- 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 ]
- To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 3 months ]
- To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 36 months ]
- To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 3 months ]
- To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 36 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786331
Contact: Luca Boni, MD | +39 0557947553 | bonil@aou-careggi.toscana.it |

Principal Investigator: | Andrea Ardizzoni, MD | Gruppo Oncologico Italiano di Ricerca Clinica |
Responsible Party: | Dr. Corrado Boni, GOIRC |
ClinicalTrials.gov Identifier: | NCT00786331 |
Other Study ID Numbers: |
GOIRC 02/2006 EudraCT number 2006-004009-24 |
First Posted: | November 6, 2008 Key Record Dates |
Last Update Posted: | August 3, 2009 |
Last Verified: | July 2009 |
second line treatment pemetrexed carboplatin |
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