Status:
COMPLETED
Docetaxel/Pemetrexed as 1st Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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
Detailed Description
Docetaxel as single-agent therapy (100 mg/m2 and 75 mg/m2, every 3 weeks) produces response rates of 26% to 54%. Docetaxel has proven superior compared to best supportive care (BSC) in chemotherapy-na...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00684099
Start Date
May 1 2006
End Date
May 1 2009
Last Update
December 15 2009
Active Locations (8)
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1
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
2
"IASO" General Hospital of Athnes, Dep of Medical Oncology
Athens, Greece
3
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
4
Air Forces Military Hospital, Dep of Medical Oncology
Athens, Greece