Overview

Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
Summary
This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Carboplatin
Cisplatin
Pemetrexed
Criteria
Inclusion Criteria:

- Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV

- No previous systemic chemotherapy for this cancer

- At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria
In Solid Tumors (RECIST) criteria

- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate
organ function

- Prior radiation therapy allowed but limited to <25% of the patient's bone marrow

Exclusion Criteria:

- Serious concomitant systemic disorder or active infection

- Mild to moderate renal insufficiency, but unable to interrupt salicylates or other
nonsteroidal anti-inflammatory drugs

- Symptomatic central nervous system (CNS) metastases requiring concurrent
corticosteroid therapy

- Presence of clinically significant third-space fluid collections