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

NCT00906061 | Unknown Phase 2

• 1 other identifier: CPNM-PS2-07
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Small Cell; Lung Neoplasms; Docetaxel; Gemcitabine; ECOG 2

Outcome Measures

Primary Outcomes (1)

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

  2 and 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 Docetaxel DRUG

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Arnau de Vilanova: lead

Study Sites (12)

Hospital Virgen de los Lirios

Alcoy, Alicante, 03804, Spain

RECRUITING

Hospital Universitario de Alicante

Alicante, Alicante, 03010, Spain

RECRUITING

Hospital San Juan de Alicante

Alicante, Alicante, 03550, Spain

RECRUITING

Hospital Clínica de Benidorm

Benidorm, Alicante, 03501, Spain

RECRUITING

Hospital General de Elda

Elda, Alicante, 03600, Spain

RECRUITING

Hospital Althaia, Xarxa Asistencial de Manresa

Manresa, Barcelona, 08243, Spain

RECRUITING

Hospital Provincial de Castellón

Castellon, Castellón, 12002, Spain

RECRUITING

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

RECRUITING

Hospital Universitario La Fe

Valencia, Valencia, 46009, Spain

RECRUITING

Instituto Valenciano de Oncología

Valencia, Valencia, 46009, Spain

RECRUITING

Hospital Arnau de Vilanova

Valencia, Valencia, 46015, Spain

RECRUITING

Hospital Universitario Dr. Peset

Valencia, Valencia, 46017, Spain

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell; Lung Neoplasms

Interventions

Gemcitabine; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Oscar Juan, Doctor

  Hospital Arnau de Vilanova de Valencia

  STUDY DIRECTOR

• Alfredo Sanchez, 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 Gomez, 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

• Juan L. Martí, Doctor

  Hospital Universitario de Alicante

  PRINCIPAL INVESTIGATOR

• Silvia Catot, Doctor

  Hospital Althaia, Xarxa Asistencial de Manresa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Juan, Doctor

CONTACT

0034963868501; juan_osc@gva.es

Vicente Alberola, Doctor

CONTACT

0034649974055; alberola_vicara@gva.es

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: October 1, 2009
• Study Completion: October 1, 2011
• Last Updated: May 21, 2009

Record last verified: 2009-05

Locations

ES (12)