Lung CancerPhase 2NCT00278460
Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing docetaxel and gemcitabine hydrochloride in people with Lung Cancer, run by Wake Forest University Health Sciences.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- docetaxel and gemcitabine hydrochloride
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Nov 2000to Sep 2007
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IIIB or IV non-small cell lung cancer, including any of the following types:
- Squamous cell carcinoma
- Adenocarcinoma, including bronchoalveolar cell adenocarcinoma
- Large cell anaplastic carcinoma, including giant and clear cell carcinomas
- Histologic or cytologic documentation of recurrence is required
- Measurable or evaluable disease, defined as any mass reproducibly measurable in 2 perpendicular diameters by physical examination or imaging
- The following lesions are not considered measurable or evaluable:
- Bone disease only
- Pleural or pericardial effusions
- Previously irradiated lesions, unless subsequent progression is documented
- CNS metastases allowed provided the patient undergoes at least 2 weeks of radiotherapy prior to study entry
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Negative pregnancy test
- CALGB performance status ≤ 1
- Life expectancy ≥ 3 months
- Granulocyte count > 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 2 times normal
- Bilirubin normal
- SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase ≤ 1.5 times ULN OR
- Alkaline phosphatase 4 times ULN and SGOT and/or SGPT normal
- Ejection fraction normal by ECHO or MUGA
- No history of congestive heart failure
- No psychiatric illness that would preclude study compliance
- No serious medical or psychiatric illness that would preclude giving informed consent or limit survival to < 3 months
- No active uncontrolled bacterial, fungal, or viral infection
- No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or breast, basal cell or squamous carcinoma of the skin, or other surgically resected non-recurrent primary tumor not treated with adjuvant radiotherapy or chemotherapy
- No pre-existing peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior major surgery and recovered from acute effects
- At least 2 weeks since prior palliative radiotherapy and recovered from acute toxic effects
- Any persistent toxicity (e.g., alopecia or hyperpigmentation) not associated with clinical morbidity allowed
- No prior chemotherapy
- No concurrent cranial or thoracic radiation therapy
- No concurrent cytotoxic or hormonal therapy
- Concurrent palliative radiotherapy allowed for relief of localized pain and obstruction
About this study
Official title: A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate of patients with recurrent stage IIIB and IV non-small cell lung cancer treated with gemcitabine hydrochloride and docetaxel.
- Determine the overall and progression-free survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
Secondary
- Determine the duration of response in patients treated with this regimen.
OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
- 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, bronchoalveolar cell lung cancer, large cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
40 milligrams per meter squared infused over 30 minutes on day 1 and 8, repeated every 21 days
800 milligrams per meter squared intraveneously for two consecutive weeks followe by one week of no treatment then repeated.
What is being measured
The primary outcome is the main question the study is designed to answer.
patient response rate to weekly taxotere and gemcitabine
Measured: 6 weeks
Secondary outcomes (1)
Evaluate toxicity of weekly Taxotere and Gemcitabine
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startNov 2000
- Primary completionFeb 2006
- Study completionSep 2007
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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Antonius A. Miller, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278460
- Sponsor's protocol ID
- CDR0000462116
- Other IDs
- CCCWFU-62199, AVENTIS-CCCWFU-62199, AG-CCCWFU-62199, CCCWFU-BG99-322
- Status last verified
- Jul 2012
- First submitted
- 16 Jan 2006
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00278460
- Acronym / sponsor ID
- CDR0000462116
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2000
- Primary completion
- Feb 2006 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 18 Jan 2006 (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, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the response rate of patients with recurrent stage IIIB and IV non-small cell lung cancer treated with gemcitabine hydrochloride and docetaxel.
- Determine the overall and progression-free survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
Secondary
- Determine the duration of response in patients treated with this regimen.
OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 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 |
|---|---|---|
| docetaxel40 milligrams per meter squared infused over 30 minutes on day 1 and 8, repeated every 21 days | Drug | – |
| gemcitabine hydrochloride800 milligrams per meter squared intraveneously for two consecutive weeks followe by one week of no treatment then repeated. | Drug | – |
Primary outcome
patient response rate to weekly taxotere and gemcitabine
Time frame: 6 weeks
1 secondary outcome
Evaluate toxicity of weekly Taxotere and Gemcitabine
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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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.
Antonius A. Miller, MD study chair
Wake Forest University Health Sciences
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 Wake Forest University Health Sciences.
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: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
patient response rate to weekly taxotere and gemcitabine (time frame: 6 weeks). 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 19 Jan 2017.