NCT00905983

Brief Summary

Lung cancer is one of the most common malignancies worldwide and the leading cause of cancer-related deaths in Western countries. Standard treatment for patients with good performance status (PS) stage IIIB/IV NSCLC currently includes a two-drug platinum-based chemotherapy regimen, but optimum treatment for elderly patients is less well-defined due to platinum related toxicities. Several drugs with novel mechanisms of action and significant activity in NSCLC have been developed; including docetaxel and gemcitabine that are also active in patients previously treated with cisplatin-based regimens and have a more favorable toxicity profile. The more favorable toxicity profile of docetaxel and gemcitabine supports its use as first-line chemotherapy, especially in patients with severe comorbidities as elderly patients. To improve the therapeutic index of this combination, the investigators performed a study with biweekly gemcitabine and docetaxel in elderly patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2007

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 21, 2009

Status Verified

May 1, 2009

Enrollment Period

1.9 years

First QC Date

May 19, 2009

Last Update Submit

May 19, 2009

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-CellElderly patientsDocetaxelGemcitabine

Outcome Measures

Primary Outcomes (1)

  • Overall response rate = sum of complete and partial tumour responses divided by the number of included patients

    2 & 4 months

Secondary Outcomes (5)

  • Overall survival

    time from study entry to death from any cause

  • Toxicity

    biweekly

  • Duration of response

    time from first response (CR or PR) to tumor progression

  • Time to progression

    time from study entry to observed tumor progression or death due to progression disease

  • Measurement of quality of life

    28 days

Study Arms (1)

Gemcitabine and Docetaxel

EXPERIMENTAL

Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.

Drug: Gemcitabine and Docetaxel

Interventions

Gemcitabine and DocetaxelDRUG

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

Gemcitabine and Docetaxel

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of advanced NSCLC.
  • Stage III with pleural effusion and stage IV.
  • Patients are 70 years old.
  • Patients with 1 \> ECOG PS =1.
  • 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; Leukocyte count \>= 4000x10(6)/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.

You may not qualify if:

  • Prior systemic chemotherapy for advanced disease.
  • 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 to study drugs.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hospital Virgen de los Lirios

Alcoy, Alicante, 3804, Spain

Location

Hospital San Juan de Alicante

Alicante, Alicante, 03550, Spain

Location

Hospital Clínica de Benidorm

Benidorm, Alicante, 03501, Spain

Location

Hospital General de Elda

Elda, Alicante, 03600, Spain

Location

Hospital Althaia, Xarxa Asistencial de Manresa

Manresa, Barcelona, 08243, Spain

Location

Hospital Provincial de Castellón

Castellon, Castellón, 12002, Spain

Location

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

Location

Hospital Universitario La Fe

Valencia, Valencia, 46009, Spain

Location

Instituto Valenciano de Oncología

Valencia, Valencia, 46009, Spain

Location

Hospital Arnau de Vilanova

Valencia, Valencia, 46015, Spain

Location

Hospital Universitario Dr. Peset

Valencia, Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma

Interventions

GemcitabineDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Oscar Juan, Doctor

    Hospital Arnau de Vilanova de Valencia

    STUDY DIRECTOR

  • Alfredo Sánchez, Doctor

    Hospital Provincial de Castellón

    PRINCIPAL INVESTIGATOR

  • José Muñoz, Doctor

    H. Universitario Dr. Peset

    PRINCIPAL INVESTIGATOR

  • Sonia Maciá, Doctor

    Hospital General de Elda

    PRINCIPAL INVESTIGATOR

  • Vicente Giner, Doctor

    Hospital de Sagunto

    PRINCIPAL INVESTIGATOR

  • José Gómez, Doctor

    Hospital Universitario La Fe

    PRINCIPAL INVESTIGATOR

  • Gaspar Esquerdo, Doctor

    Hospital Clínica de Benidorm

    PRINCIPAL INVESTIGATOR

  • Antonio López, Doctor

    Hospital San Juan de Alicante

    PRINCIPAL INVESTIGATOR

  • Francisco Aparisi, Doctor

    Hospital Virgen de los Lirios

    PRINCIPAL INVESTIGATOR

  • Miguel A. Muñoz, Doctor

    Instituto Valenciano de Oncología

    PRINCIPAL INVESTIGATOR

  • Silvia Catot, Doctor

    Hospital Althaia, Xarxa Asistencial de Manresa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

October 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2011

Last Updated

May 21, 2009

Record last verified: 2009-05

Locations

ES(11)