Docetaxel/Pemetrexed as 1st Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will determine the maximum tolerated dose the recommended phase II dose and the efficacy of this combination in locally advanced or metastatic NSCLC patients

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Docetaxel; Pemetrexed

Criteria

Inclusion Criteria:

• Histologically confirmed inoperable (stage IIIB-IV) NSCLC. A block of Formaline Fixed Parafine Embedded tissue representative for the primary diagnosis should be available for genomic analysis (phase II part)

• Written informed consent

• Prior chemotherapy with platinum compounds in association with or without taxanes (phase I part)

• Previously untreated with docetaxel and pemetrexed (phase II part)

• Bidimensionally, non-irradiated measurable disease (according to RECIST criteria) (phase II)

• Age ≥18 years

• World Health Organization (WHO) performance status (PS) 0-2

• Life expectancy of at least 12 weeks

• Serum bilirubin less than 1.5 times the upper normal limit (UNL)

• AST and ALT less than 2.5 times the UNL in the absence of demonstrable liver metastases, or less than 5 times the UNL in the presence of liver metastases.

• Serum creatinine less than 1.5 times the UNL

• Neutrophil count more than 1.5x 109 /L

• Platelet count more than 100x 109 /L

Exclusion Criteria:

• Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ)

• Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator)

• Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy

• Patients with unstable central nervous system metastases

• Malnutrition (loss of ≥ 20% of the original body weight)

• Performance status: 4

• Psychiatric illness or social situation that would preclude study compliance

• Pregnant or lactating women