Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075517
First received: January 9, 2004
Last updated: July 23, 2008
Last verified: July 2007
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Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: docetaxel Drug: gemcitabine hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Response rate [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
| Study Start Date: | September 2003 |
OBJECTIVES:
Primary
- Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel.
Secondary
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the tolerance profile of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive docetaxel IV over 1 hour and gemcitabine IV over 2 hours on day 1. Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after courses 6 and 12, and then every 3 months thereafter.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer of 1 of the following histologic subtypes:
- Epidermoid carcinoma
- Large cell carcinoma
- Adenocarcinoma
- Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease
- Inoperable disease
Measurable disease
- At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Platelet count at least 100,000/mm^3
- Absolute neutrophil count at least 2,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- Bilirubin no greater than normal
- Transaminases no greater than 1.5 times normal
- Alkaline phosphatase no greater than 2.5 times normal
Renal
- Creatinine no greater than 2.3 mg/dL
Cardiovascular
- No uncontrolled cardiac insufficiency
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after study therapy
- No uncontrolled infection
- No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- No grade 3 or 4 brain disorder
- No intolerance to polysorbate 80 or cortisones
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy, including taxanes or gemcitabine
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to more than 20% of the bone marrow
- No prior radiotherapy for lung cancer
- At least 4 weeks since other prior radiotherapy and recovered
Surgery
- No prior surgery for lung cancer
Other
- More than 30 days since prior clinical trial participation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075517
Locations
| France | |
| Hopital Avicenne | |
| Bobigny, France, 93009 | |
| Centre Jean Bernard | |
| Le Mans, France, 72000 | |
| Hopital Perpetuel Secours | |
| Levallois-Perret, France, 92300 | |
| Centre de Radiotherapie et Oncologie Saint-Faron | |
| Mareuil Les Meaux, France, 77100 | |
| Clinique de Docteur Terrioux | |
| Meaux, France, 77100 | |
| American Hospital of Paris | |
| Neuilly Sur Seine, France, F-92202 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| Clinique les Bleuets | |
| Reims, France, 51100 | |
| Centre Rene Huguenin | |
| Saint Cloud, France, 92211 | |
| Clinique Francois | |
| Saint-Dizier, France, 52100 | |
| Hopital Paul Brousse | |
| Villejuif, France, 94804 | |
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
| Investigator: | Philippe Terrioux, MD | Clinique de Docteur Terrioux |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00075517 History of Changes |
| Other Study ID Numbers: | CDR0000346806, FRE-GERCOR-DOCEGEM-B00-2, EU-20331 |
| Study First Received: | January 9, 2004 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung large cell lung cancer squamous cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Docetaxel Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 23, 2013