Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00905983
• Other study ID #: CPNM-ANC-07
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 19, 2009
• Last updated: May 19, 2009
• Start date: October 2007
• Est. completion date: September 2011

Study information

• Verified date: May 2009
• Source: Hospital Arnau de Vilanova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: September 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Virgen de los Lirios	Alcoy	Alicante
Spain	Hospital San Juan de Alicante	Alicante
Spain	Hospital Clínica de Benidorm	Benidorm	Alicante
Spain	Hospital Provincial de Castellón	Castellón de la Plana	Castellón
Spain	Hospital General de Elda	Elda	Alicante
Spain	Hospital Althaia, Xarxa Asistencial de Manresa	Manresa	Barcelona
Spain	Hospital de Sagunto	Sagunto	Valencia
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Universitario Dr. Peset	Valencia
Spain	Hospital Universitario La Fe	Valencia
Spain	Instituto Valenciano de Oncología	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Arnau de Vilanova

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate = sum of complete and partial tumour responses divided by the number of included patients		2 & 4 months	No
Secondary	Overall survival		time from study entry to death from any cause	No
Secondary	Toxicity		biweekly	Yes
Secondary	Duration of response		time from first response (CR or PR) to tumor progression	No
Secondary	Time to progression		time from study entry to observed tumor progression or death due to progression disease	No
Secondary	Measurement of quality of life		28 days	No