Lung CancerPhase 2NCT00002972
Paclitaxel in Treating Patients With Lung Cancer
A Phase 2 study testing paclitaxel in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 5 sites in 5 countries.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have unresectable stage IIIB, stage IV or recurrent lung cancer. 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?
- paclitaxel
- How many people
- 25 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Jan 1997to Aug 2002
- 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 proven bronchoalveolar carcinoma (BAC) based on these criteria:
- Absence of primary adenocarcinoma elsewhere
- Absence of a demonstrable central bronchogenic origin
- A peripheral location in the lung parenchyma
- Intact interstitial framework of the lung
- A histological appearance setting it apart from other tumors, with a characteristic pattern of growth: cuboidal or cylindrical cells lining up the alveolar septa with preservation of basic pulmonary architecture
- Must be unresectable Stage IIIB, IV, or recurrent BAC
- Evidence of multinodular lesions involving the lungs bilaterally or unilaterally (in the latter the lesions must involve more than one lobe)
- At least one target lesion bidimensionally measurable that has not undergone prior irradiation
- No CNS disease
PATIENT CHARACTERISTICS:
Age:
- 18 to 75 (inclusive)
Performance status:
- ECOG 0-2
Life expectancy:
- Greater than 3 months
Hematopoietic:
- ANC at least 1,500/mm^3
Hepatic:
- Bilirubin less than 2 times upper limit of normal
- SGOT, SGPT, and alkaline phosphatase less than 2 times upper limit of normal
Renal:
- Creatinine less than 1.5 times upper limit of normal
Cardiovascular:
- No history of ischemic or congestive heart disease
- No arrhythmia requiring chronic cardiopulmonary medications
- No history of clinically or electrographically documented myocardial infarction
Other:
- No preexisting motor or other serious sensory neurotoxicity
- No active or prior second primary cancer except basal cell carcinoma of the skin or carcinoma in situ of the cervix
- No clinical evidence of uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test 72 hours prior to start of study medication
- Adequate contraception required of all fertile patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since radiotherapy
- Must have at least one bidimensional lesion outside the irradiated fields
Surgery:
- Fully recovered from any prior major surgery
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Italy1 site
Azienda Ospedale S. Luigi - Universita Di Torino
Orbassano, (Torino), 10043
About this study
Official title: Phase II Study on TAXOL in Bronchioalveolar Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have unresectable stage IIIB, stage IV or recurrent lung cancer.
Read the detailed description
OBJECTIVES:
- Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma (BAC).
- Assess the duration of response in patients presenting with an objective response.
- Characterize the acute side effects of paclitaxel in patients with BAC.
- Assess the role of some biological parameters in the natural history and the response to therapy of BAC; evaluate the expression of Ki67, p53, and K-ras mutation.
OUTLINE: This is an open label, nonrandomized, multicenter study.
Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or normal saline. Patients are treated for a minimum of 2 cycles unless serious toxicity or complication occur.
Disease is assessed every 6 weeks until documented progression; treatment side effects are assessed separately for each cycle of therapy. Treatment is given up to a maximum of 6 cycles of therapy or until disease progression, unacceptable toxicity, or patient refusal occurs.
PROJECTED ACCRUAL: 16 or 25 patients will be accrued.
- Conditions
- Lung Cancer
- Being tested
- paclitaxel
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung
- 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.
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2003 (estimated)
- Study startJan 1997
- Primary completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Giorgio Scagliotti, MD, PhD, Study chair, Azienda Ospedale S. Luigi at University of Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002972
- Sponsor's protocol ID
- EORTC-08956
- Other IDs
- EORTC-08956
- Status last verified
- Jun 2012
- First submitted
- 1 Nov 1999
- Last updated
- 2 Jul 2012
- Results posted
- No
Publications
Scagliotti GV, Smit E, Bosquee L, O'Brien M, Ardizzoni A, Zatloukal P, Eberhardt W, Smid-Geirnaerdt M, de Bruin HG, Dussenne S, Legrand C, Giaccone G; European Organisation for Research and Treatment of Cancer (EORTC) Lung Cancer Group (LCG). A phase II study of paclitaxel in advanced bronchioloalveolar carcinoma (EORTC trial 08956). Lung Cancer. 2005 Oct;50(1):91-6. doi: 10.1016/j.lungcan.2005.05.012.
PubMed 16019107
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on TAXOL in Bronchioalveolar Carcinoma
- ClinicalTrials.gov ID
- NCT00002972
- Acronym / sponsor ID
- EORTC-08956
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Jan 1997
- Primary completion
- Aug 2002 (actual)
- First posted
- 17 Apr 2003 (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 use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have unresectable stage IIIB, stage IV or recurrent lung cancer.
Detailed description
OBJECTIVES:
- Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma (BAC).
- Assess the duration of response in patients presenting with an objective response.
- Characterize the acute side effects of paclitaxel in patients with BAC.
- Assess the role of some biological parameters in the natural history and the response to therapy of BAC; evaluate the expression of Ki67, p53, and K-ras mutation.
OUTLINE: This is an open label, nonrandomized, multicenter study.
Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or normal saline. Patients are treated for a minimum of 2 cycles unless serious toxicity or complication occur.
Disease is assessed every 6 weeks until documented progression; treatment side effects are assessed separately for each cycle of therapy. Treatment is given up to a maximum of 6 cycles of therapy or until disease progression, unacceptable toxicity, or patient refusal occurs.
PROJECTED ACCRUAL: 16 or 25 patients will be accrued.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 |
|---|---|---|
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
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 2 Jul 2012.
- Results publication: PubMed 16019107Scagliotti GV, Smit E, Bosquee L, O'Brien M, Ardizzoni A, Zatloukal P, Eberhardt W, Smid-Geirnaerdt M, de Bruin HG, Dussenne S, Legrand C, Giaccone G; European Organisation for Research and Treatment of Cancer (EORTC) Lung Cancer Group (LCG). A phase II study of paclitaxel in advanced bronchioloalveolar carcinoma (EORTC trial 08956). Lung Cancer. 2005 Oct;50(1):91-6. doi: 10.1016/j.lungcan.2005.05.012.
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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.
Giorgio Scagliotti, MD, PhD study chair
Azienda Ospedale S. Luigi at University of Torino
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel in people with Lung Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 5 sites in 5 countries.
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 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Czechia, Germany, Italy, Netherlands. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002972, which also lists 1 linked publication.
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 2 Jul 2012.