Lung CancerPhase 2NCT00075517
Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing docetaxel and gemcitabine hydrochloride in people with Lung Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 12 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- docetaxel and gemcitabine hydrochloride
- How many people
- Not given
- Where
- 12 sitesFrance
- Study dates
- Sep 2003to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Hopital Avicenne
Bobigny, 93009
Centre Jean Bernard
Le Mans, 72000
Hopital Perpetuel Secours
Levallois-Perret, 92300
Centre de Radiotherapie et Oncologie Saint-Faron
Mareuil-lès-Meaux, 77100
Clinique de Docteur Terrioux
Meaux, 77100
American Hospital of Paris
Neuilly-sur-Seine, F-92202
Hopital Tenon
Paris, 75970
Clinique les Bleuets
Reims, 51100
Polyclinique De Courlancy
Reims, F-51100
Centre Rene Huguenin
Saint-Cloud, 92211
Clinique Francois
Saint-Dizier, 52100
Hopital Paul Brousse
Villejuif, 94804
About this study
Official title: Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer
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.
Read the detailed description
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.
- Conditions
- Lung Cancer
- Being tested
- docetaxel, gemcitabine hydrochloride
- Keywords
- 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
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Secondary outcomes (4)
Progression-free survival
Overall survival
Tolerability
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2004 (estimated)
- Study startSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Investigators
- Philippe Terrioux, MD, Clinique de Docteur Terrioux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075517
- Sponsor's protocol ID
- CDR0000346806
- Other IDs
- FRE-GERCOR-DOCEGEM-B00-2, EU-20331
- Status last verified
- Jul 2007
- First submitted
- 9 Jan 2004
- Last updated
- 24 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00075517
- Acronym / sponsor ID
- CDR0000346806
- Conditions
- Lung Cancer
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- Sep 2003
- First posted
- 12 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxel | Drug | – |
| gemcitabine hydrochloride | Drug | – |
Primary outcome
Response rate
4 secondary outcomes
Progression-free survival
Overall survival
Tolerability
Quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2008.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Terrioux, MD
Clinique de Docteur Terrioux
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel and gemcitabine hydrochloride in people with Lung Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2008.