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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Unknown status

Phase

Phase 2

Locations

Spain

Study Type

Interventional

Intervention

Gemcitabine and Docetaxel

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Carcinoma, Non-Small-Cell, Elderly patients, Docetaxel, Gemcitabine

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine and Docetaxel

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival

Toxicity

Duration of response

Time to progression

Measurement of quality of life

Full Information

NCT ID

NCT00905983

First Posted

May 19, 2009

Last Updated

May 19, 2009

Sponsor

Hospital Arnau de Vilanova

1. Study Identification

Unique Protocol Identification Number

NCT00905983

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2007 (undefined)

Primary Completion Date

September 2009 (Anticipated)

Study Completion Date

September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Arnau de Vilanova

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell, Elderly patients, Docetaxel, Gemcitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine and Docetaxel

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine and Docetaxel

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

2 & 4 months

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

time from study entry to death from any cause

Title

Toxicity

Time Frame

biweekly

Title

Duration of response

Time Frame

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

Title

Time to progression

Time Frame

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

Title

Measurement of quality of life

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: