Docetaxel/Pemetrexed as 1st Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)
This study has been completed.
Sponsor:
Hellenic Oncology Research Group
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00684099
First received: May 22, 2008
Last updated: December 14, 2009
Last verified: December 2009
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Drug: Docetaxel Drug: Pemetrexed |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study Of The Docetaxel/Pemetrexed Combination As First Line Treatment In Patients With Advanced/Metastatic NSCLC |
Resource links provided by NLM:
Further study details as provided by Hellenic Oncology Research Group:
Primary Outcome Measures:
- Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Response rate for the docetaxel/pemetrexed doublet [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | May 2006 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Docetaxel
Docetaxel at starting dose of 65 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
Other Name: Taxotere
Drug: Pemetrexed
Pemetrexed at starting dose of 400 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
Other Name: Alimta
|
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-naïve as well as in platinum pretreated patients. In addition, docetaxel is active in cisplatin refractory or resistant patients, producing responses ranging from 18% to 25%, implying a lack of cross-resistance between docetaxel and cisplatin, probably due to their different mechanisms of action. Furthermore, docetaxel is associated with significant prolongation of survival when administered as second line therapy, in pretreated patients with advanced NSCLC. Phase II studies of pemetrexed in previously untreated patients with NSCLC have demonstrated single agent response rates of 17% to 23%. A phase II study of pemetrexed in patients with advanced NSCLC, who had progressed during or within 3 months of completing first-line chemotherapy, demonstrated a response rate of 8.9% and median survival time of 5.7 months. Multivariate analysis established an association between an increased risk of severe pemetrexed toxicity and elevated homocysteine (folate and/or B12 vitamin deficiency marker) levels. Since December 1999, all pemetrexed-treated patients are required to receive folic acid and Vitamin B12. A recently reported phase III study compared pemetrexed with docetaxel as 2nd line therapy in patients with advanced NSCLC. Treatment with pemetrexed resulted in clinically equivalent efficacy outcomes, but with significantly fewer side effects compared with docetaxel.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00684099
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684099
Locations
| Greece | |
| University General Hospital of Alexandroupolis, Dep of Medical Oncology | |
| Alexandroupolis, Greece | |
| "IASO" General Hospital of Athnes, Dep of Medical Oncology | |
| Athens, Greece | |
| "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine | |
| Athens, Greece | |
| Air Forces Military Hospital, Dep of Medical Oncology | |
| Athens, Greece | |
| Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases | |
| Athens, Greece | |
| Sotiria" General Hospital, 1st Dep of Pulmonary Diseases | |
| Athens, Greece | |
| "Diabalkaniko" Hospital of Thessaloniki | |
| Thessaloniki, Greece | |
| "Theagenion" Anticancer Hospital of Thessaloniki | |
| Thessaloniki, Greece | |
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
| Principal Investigator: | Vassilis Georgoulias, MD | University Hospital of Crete |
| Principal Investigator: | Athanasios Kotsakis, MD | University Hospital of Crete |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | V.Georgoulias, University Hospital of Crete |
| ClinicalTrials.gov Identifier: | NCT00684099 History of Changes |
| Other Study ID Numbers: | CT/05.18 |
| Study First Received: | May 22, 2008 |
| Last Updated: | December 14, 2009 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Hellenic Oncology Research Group:
|
NSCLC Pemetrexed Docetaxel |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Docetaxel Pemetrexed Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on September 30, 2016