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

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ClinicalTrials.gov Identifier: NCT00684099
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : December 15, 2009
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group

Study Description
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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

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Docetaxel Drug: Pemetrexed Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Response rate for the docetaxel/pemetrexed doublet [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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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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): NCT00684099


Locations
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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
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Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete
Principal Investigator: Athanasios Kotsakis, MD University Hospital of Crete
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: V.Georgoulias, University Hospital of Crete
ClinicalTrials.gov Identifier: NCT00684099    
Other Study ID Numbers: CT/05.18
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009
Keywords provided by Hellenic Oncology Research Group:
NSCLC
Pemetrexed
Docetaxel
Additional relevant MeSH terms:
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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