Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients

May 19, 2009 updated by: Hospital Arnau de Vilanova

Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2

There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.

This low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status.

In these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer.

The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

76

Phase

  • Phase 2

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

  • Spain
      • Alicante, Spain, 03550
        • Recruiting
        • Hospital San Juan de Alicante
      • Alicante, Spain, 03010
        • Recruiting
        • Hospital Universitario de Alicante
        • Contact:
        • Principal Investigator:
          • Juan L. Martí, Doctor
      • Valencia, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncologia
        • Contact:
        • Principal Investigator:
          • Miguel A. Muñoz, Doctor
      • Valencia, Spain, 46017
        • Recruiting
        • Hospital Universitario Dr. Peset
      • Valencia, Spain, 46015
        • Recruiting
        • Hospital Arnau de Vilanova
      • Valencia, Spain, 46009
        • Recruiting
        • Hospital Universitario La Fe
        • Contact:
        • Principal Investigator:
          • José Gómez, Doctor
    • Alicante
      • Alcoy, Alicante, Spain, 03804
        • Recruiting
        • Hospital Virgen de los Lirios
      • Benidorm, Alicante, Spain, 03501
        • Recruiting
        • Hospital Clínica de Benidorm
      • Elda, Alicante, Spain, 03600
        • Recruiting
        • Hospital General de Elda
    • Barcelona
      • Manresa, Barcelona, Spain, 08243
        • Recruiting
        • Hospital Althaia, Xarxa Asistencial de Manresa
        • Contact:
        • Principal Investigator:
          • Silvia Catot, Doctor
    • Castellón
      • Castellón de la Plana, Castellón, Spain, 12002
        • Recruiting
        • Hospital Provincial de Castellón
    • Valencia
      • Sagunto, Valencia, Spain, 46520
        • Recruiting
        • Hospital de Sagunto
        • Contact:

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of advanced NSCLC.
  • Stage III with pleural effusion and stage IV.
  • Patients with ECOG PS 2.
  • Patients must have at least one measurable lesion, no previously irradiated.
  • Life expectancy of at least 12 weeks.

  • Adequate organ function according to the following criteria:

    • Bone marrow: ANC => 2.0x10(9)cells/L; Platelet count => 100x10(9)cells/L; Hemoglobin => 10 g/dL.
    • Liver function: Bilirubin <= 1.5 X ULN; Alkaline phosphatase <= 5 x ULN; AST and ALT <= 1.5 x ULN.
    • Renal function:serum creatinine <= 2mg/dL.

Exclusion Criteria:

  • Prior systemic chemotherapy for advanced disease.
  • Prior radiotherapy for NSCLC.
  • Patients with symptomatic brain metastases.
  • No measurable bone metastases or malignant pleural effusion as only measurable lesion.
  • History of prior malignancies, except curatively treated in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least five years.
  • History of hypersensitivity reaction study drugs.
  • Pregnant or lactating women (women of childbearing potential must use adequate contraception).
  • Concurrent treatment with other experimental drugs.
  • Current peripheral neuropathy NCI grade 2.
  • Participation in clinical trials within 30 days of study entry.
  • Major surgery, open biopsy or traumatic lesion 28 days before to study start.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Gemcitabine and Docetaxel
Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.
Drug: Gemcitabine and Docetaxel
Docetaxel 50 mg/m2, IV, and Gemcitabine 2000 mg/m2, IV, on day 1 and 14 of each 28 day cycle. Number of Cycles: 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate = sum of complete and partial tumour responses divided by the number of included patients
Time Frame: 2 and 4 months
2 and 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Time from study entry to death from any cause
Time from study entry to death from any cause
Toxicity
Time Frame: Biweekly
Biweekly
Duration of response
Time Frame: time from first response (CR or PR) to tumor progression
time from first response (CR or PR) to tumor progression
Time to progression
Time Frame: time from study entry to observed tumor progression or death due to progression disease
time from study entry to observed tumor progression or death due to progression disease
Measurement of quality of life
Time Frame: 28 days
28 days

Collaborators and Investigators

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

Sponsor

Hospital Arnau de Vilanova

Investigators

  • Principal Investigator: Juan L. Martí, Doctor, Hospital Universitario de Alicante

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

October 1, 2007

Primary Completion (ANTICIPATED)

October 1, 2009

Study Completion (ANTICIPATED)

October 1, 2011

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (ESTIMATE)

May 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 21, 2009

Last Update Submitted That Met QC Criteria

May 19, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPNM-PS2-07

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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