Lung CancerPhase 2NCT00118131
Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing cisplatin and docetaxel in people with Lung Cancer, run by University of Medicine and Dentistry of New Jersey at 13 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, 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?
- cisplatin and docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2003to Feb 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or cytologically confirmed non-small cell lung cancer, meeting 1 of the following stage criteria:
- Stage IIIB disease with malignant pericardial or malignant pleural effusions, as indicated by 1 of the following:
- Positive cytology
- Exudative effusion AND lactic dehydrogenase (LDH) > 200 IU with effusion/serum LDH ratio ≥ 0.6
- Stage IV disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan
- Brain metastases allowed provided they have been irradiated AND are radiographically stable for ≥ 28 days after the completion of radiotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL
Hepatic
- AST and ALT normal
- Bilirubin normal
Renal
- Creatinine clearance ≥ 50 mL/min
Immunologic
- No known HIV positivity
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No clinically significant active infection
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception before, during, and for 4 weeks after completion of study treatment
- No other primary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- No other serious systemic disorder that would preclude study participation
- No other condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior antibody-based therapy that targets growth factor pathways (e.g., epidermal growth factor receptor [EGFR]) allowed provided there is disease progression during therapy and patient has recovered
- No concurrent immunotherapy
- No concurrent prophylactic colony-stimulating factors
- No concurrent interleukin-11
Chemotherapy
- No prior cytotoxic chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy for the malignancy
Radiotherapy
- See Disease Characteristics
- More than 28 days since prior radiotherapy and recovered
- No prior radiotherapy to ≥ 25% of the bone marrow
- No prior radiotherapy to sites of measurable disease unless there is documented tumor progression after completion of radiotherapy
- No concurrent radiotherapy
Surgery
- No concurrent surgery for the malignancy
Other
- More than 3 weeks since prior investigational drugs
- Prior oral small molecule drug therapy that targets growth factor pathways (e.g., EGFR) allowed provided there is disease progression during therapy and patient has recovered
- No other concurrent investigational or commercial agents or therapies for the malignancy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Central Jersey Oncology Center, PA - East Brunswick
East Brunswick, New Jersey, 08816
JFK Medical Center in Edison
Edison, New Jersey, 08818
CentraState Medical Center
Freehold, New Jersey, 07728
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, 08690
Monmouth Medical Center
Long Branch, New Jersey, 07740
Mountainside Hospital Cancer Center
Montclair, New Jersey, 07042
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Saint Peter's University Hospital
New Brunswick, New Jersey, 08903
UMDNJ - University Hospital
Newark, New Jersey, 07103
Raritan Bay Medical Center
Perth Amboy, New Jersey, 08861
Somerset Medical Center
Somerville, New Jersey, 08876
Overlook Hospital
Summit, New Jersey, 07901
About this study
Official title: Phase II Study of Weekly Docetaxel Together With Weekly Cisplatin in Chemotherapy-Naive Patients With Stage IV or Select Stage IIIB (Malignant Effusion) Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, 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 docetaxel together with cisplatin works in treating patients with stage III or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the antitumor activity of docetaxel and cisplatin, as measured by tumor response rate, in patients with chemotherapy-naïve stage IIIB or IV non-small cell lung cancer.
Secondary
- Determine the duration of response in patients treated with this regimen.
- Determine time to disease progression in patients treated with this regimen.
- Determine the 1-year survival rate in patients treated with this regimen.
- Determine the median survival time in patients treated with this regimen.
- Correlate aneuploidy (as determined by DNA histograms) and immunohistochemical expression of stathmin, Aurora-A, and survivin with response in patients treated with this regimen.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour once on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 13-19 months.
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel and Cisplatin | Experimental | A cycle is defined as an interval of 28 days.
Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).
Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).
Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15. Receives: Drug: cisplatin; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Tumor Response Rate
Patients experiencing complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Measured: 7 years
Secondary outcomes (3)
Time to Progressive Disease
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 8 years
1-year Survival Rate
Measured: 1 year
Median Survival Time
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2005 (estimated)
- Study startDec 2003
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Aventis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Joseph Aisner, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118131
- Sponsor's protocol ID
- CDR0000433488
- Other IDs
- P30CA072720, CINJ-030302, CINJ-NJ1503
- Status last verified
- Jul 2023
- First submitted
- 8 Jul 2005
- Last updated
- 15 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Weekly Docetaxel Together With Weekly Cisplatin in Chemotherapy-Naive Patients With Stage IV or Select Stage IIIB (Malignant Effusion) Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00118131
- Acronym / sponsor ID
- CDR0000433488
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Aventis Pharmaceuticals
- Study start
- Dec 2003
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Jul 2005 (estimated)
- Results
- Posted 25 Nov 2013
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 docetaxel and cisplatin, 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 docetaxel together with cisplatin works in treating patients with stage III or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the antitumor activity of docetaxel and cisplatin, as measured by tumor response rate, in patients with chemotherapy-naïve stage IIIB or IV non-small cell lung cancer.
Secondary
- Determine the duration of response in patients treated with this regimen.
- Determine time to disease progression in patients treated with this regimen.
- Determine the 1-year survival rate in patients treated with this regimen.
- Determine the median survival time in patients treated with this regimen.
- Correlate aneuploidy (as determined by DNA histograms) and immunohistochemical expression of stathmin, Aurora-A, and survivin with response in patients treated with this regimen.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour once on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 13-19 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel and Cisplatin | Experimental | Drug: cisplatin, Drug: docetaxelA cycle is defined as an interval of 28 days. Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2). Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2). Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15. |
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 |
|---|---|---|
| cisplatin | Drug | Docetaxel and Cisplatin |
| docetaxel | Drug | Docetaxel and Cisplatin |
Primary outcome
Overall Tumor Response Rate
Time frame: 7 years
Patients experiencing complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
3 secondary outcomes
Time to Progressive Disease
Time frame: 8 years
1-year Survival Rate
Time frame: 1 year
Median Survival Time
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph Aisner, MD principal investigator
Rutgers Cancer Institute of New Jersey
13 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 cisplatin and docetaxel in people with Lung Cancer, run by University of Medicine and Dentistry of New Jersey at 13 sites in United States.
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: stopped early, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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?
Yes. Results are posted in the registry (first posted 25 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Tumor Response Rate (time frame: 7 years). 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 15 Aug 2023.