search
Back to results

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

Primary Purpose

Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
Docetaxel
Pemetrexed
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring NSCLC, Pemetrexed, Docetaxel

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University General Hospital of Alexandroupolis, Dep of Medical Oncology
  • "IASO" General Hospital of Athnes, Dep of Medical Oncology
  • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
  • Air Forces Military Hospital, Dep of Medical Oncology
  • Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
  • Sotiria" General Hospital, 1st Dep of Pulmonary Diseases
  • "Diabalkaniko" Hospital of Thessaloniki
  • "Theagenion" Anticancer Hospital of Thessaloniki

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet

Secondary Outcome Measures

Response rate for the docetaxel/pemetrexed doublet

Full Information

First Posted
May 22, 2008
Last Updated
December 14, 2009
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
search

1. Study Identification

Unique Protocol Identification Number
NCT00684099
Brief Title
Docetaxel/Pemetrexed as 1st Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC)
Official Title
A Phase I/II Study Of The Docetaxel/Pemetrexed Combination As First Line Treatment In Patients With Advanced/Metastatic NSCLC
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

Data Monitoring Committee
No

5. Study Description

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-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
NSCLC, Pemetrexed, Docetaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Docetaxel at starting dose of 65 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
Pemetrexed at starting dose of 400 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles
Primary Outcome Measure Information:
Title
Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Response rate for the docetaxel/pemetrexed doublet
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vassilis Georgoulias, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Athanasios Kotsakis, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
"IASO" General Hospital of Athnes, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
Sotiria" General Hospital, 1st Dep of Pulmonary Diseases
City
Athens
Country
Greece
Facility Name
"Diabalkaniko" Hospital of Thessaloniki
City
Thessaloniki
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
21069335
Citation
Kotsakis A, Agelaki S, Vardakis N, Stathopoulos G, Vamvakas L, Kalykaki A, Kentepozidis N, Kontopodis E, Sfakiotaki G, Mavroudis D, Georgoulias V. A dose-escalation study of pemetrexed and docetaxel in non-small-cell lung cancer. Cancer Chemother Pharmacol. 2011 Aug;68(2):415-22. doi: 10.1007/s00280-010-1508-5. Epub 2010 Nov 11.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs