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

December 14, 2009 updated by: Hellenic Oncology Research Group

A Phase I/II Study Of The Docetaxel/Pemetrexed Combination As First Line Treatment In Patients With Advanced/Metastatic NSCLC

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis, 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
        • "IASO" General Hospital of Athnes, Dep of Medical Oncology
      • Athens, Greece
        • Sotiria" General Hospital, 1st Dep of Pulmonary Diseases
      • Thessaloniki, Greece
        • "Theagenion" Anticancer Hospital of Thessaloniki
      • Thessaloniki, Greece
        • "Diabalkaniko" Hospital of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Alimta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate for the docetaxel/pemetrexed doublet
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

Investigators

  • Principal Investigator: Vassilis Georgoulias, MD, University Hospital of Crete
  • Principal Investigator: Athanasios Kotsakis, MD, University Hospital of Crete

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

May 22, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 26, 2008

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 14, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/05.18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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