Lung CancerPhase 2NCT00664105
Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Carboplatin, Docetaxel and radiation therapy in people with Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 15 sites in United States.
Trial summary
RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of docetaxel as a multimodality regimen in this patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Carboplatin, Docetaxel and radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 15 sitesUnited States
- Study dates
- Feb 2004to Jun 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must voluntarily sign and date an informed consent before the initiation of any study procedures
- Patients must have non-metastatic, inoperable, Stage IIIA or IIIB histologically or cytologically documented NSCLC without evidence of malignant pleural effusion
- Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy or surgical resection for treatment of NSCLC
- Patients must have at least one site of unidirectionally measurable disease
- Patients must be ≥ 3 weeks from a formal exploratory thoracotomy
- Patients must have a Radiation Oncology and Medical Oncology consult and approval prior to study entry
Show all 18Show fewer
- Patients must be ≥ 18 years of age
- Women of childbearing potential must have a negative baseline serum pregnancy within 7 days prior to Week 1, Day 1 and must not be breast feeding.
- Women of childbearing potential and men with a sexual partner of child bearing potential must use an effective method of contraception beginning prior to study entry, for the duration of the study participation and for a minimum of 3 months after the last dose of chemotherapy.
- Patients must have adequate hepatic, renal, lung and bone marrow function as defined below:
- Absolute neutrophil count (ANC) > 1,500/mm3
- Hemoglobin > 9.0 gm/dL
- Creatinine < 1.5
- Platelets > 100,000/mm3
- Total bilirubin within normal limits (WNL)
- AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility, as per chart on page 10 of the protocol.
- Calculated CrCl > 50 ml/min (via Cockroft-Gault formula).
- Forced expiratory volume in 1 second (FEV 1) > 800 ml
Who cannot join
- Known hypersensitivity to drugs formulated with polysorbate 80
- Peripheral neuropathy Grade ≥ 2.
- Wet stage IIIB (documented malignant pleural effusion) or stage IV NSCLC
- Previous chemotherapy or radiation therapy
- Any concomitant malignancy, brain metastasis or uncontrolled, clinically significant medical or psychiatric disorder
- Pregnant or nursing women
- A greater than or equal to 10% weight loss over the past 3 months
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center
Allentown, Pennsylvania, 18103
Chesapeake Oncology Hematology Associates
Baltimore, Maryland, 21225
Erlanger Health System
Chattanooga, Tennessee, 37403
Clarksville Regional Hematology Oncology Group
Clarksville, Tennessee, 37043
University Hospital of Cleveland
Cleveland, Ohio, 44106
UT Southwestern Medical Center
Dallas, Texas, 75390
Jackson Madison County Hospital
Jackson, Tennessee, 38301
Tennessee Cancer Specialists
Knoxville, Tennessee, 37920
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
The West Clinic, PC
Memphis, Tennessee, 38120
St. Thomas Health Services
Nashville, Tennessee, 37205
Meharry Medical College
Nashville, Tennessee, 37208
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
M.D. Anderson Cancer Center, Orlando
Orlando, Florida, 32806
Swedish Cancer Institute
Seattle, Washington, 98104
About this study
Official title: PhII Study of Concurrent Chemoradiotherapy With Weekly Docetaxel, Carboplatin and Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel and Carboplatin for Locally Advanced Inoperable Non-small Cell Lung Cancer (NSCLC)
RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of docetaxel as a multimodality regimen in this patient population. Docetaxel at a dose of 20 mg/m2 appears to be a well-tolerated "weekly" dose when combined with either cisplatin 25 mg/m2 20-22 or carboplatin area under the curve (AUC) 2 23-25 concomitant with radiation therapy.
PURPOSE: To explore the potential benefits of the radiosensitizing effects of weekly docetaxel/carboplatin/radio therapy concurrent therapy followed full dose systemic docetaxel/carboplatin consolidation therapy on overall response rate, survival, progression-free survival, safety and toxicity in patients with locally advanced NSCLC.
Read the detailed description
OBJECTIVES:
Primary
- To determine the overall survival (0S) for advanced NSCLC patients receiving concurrent chemoradiotherapy with weekly docetaxel, carboplatin and radiation therapy followed by two cycles of consolidation chemotherapy with docetaxel and carboplatin.
Secondary
- To determine the overall response rate in patients treated with this regimen.
- To determine the time to disease progression in patients treated with this regimen.
- To assess the safety and tolerability of this regimen in these patients.
OUTLINE:
- This is a Phase II, open label, multi-center study to determine the overall survival rate for patients treated with concurrent chemoradiotherapy with weekly docetaxel, carboplatin and radiation followed by two cycles of consolidation chemotherapy with docetaxel and carboplatin. Eligible patients will receive concurrent therapy with docetaxel (20 mg/m2) administered weekly for seven weeks as a 30-minute intra-venous (IV) infusion followed by carboplatin (AUC 2) administered weekly for seven weeks as a 30-minute IV infusion. Concurrent radiation therapy will be administered at a dose of 1.8 Gy daily 5 days/week for 25 fractions followed by a dose of 2.0 Gy daily, 5 days/week for 9 fractions (total of 34 fractions). There will be a three-week rest period following the end of the concurrent chemotherapy after which the consolidation phase will begin. During this phase of the study, patients will be treated with docetaxel (75 mg/m2) administered as a 1-hour IV infusion followed by carboplatin (AUC 6) administered as a 30-minute IV infusion. Patient will be treated every three weeks for a total of two cycles.
- Conditions
- Lung Cancer
- Being tested
- Carboplatin, Docetaxel, radiation therapy
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB 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.
CarboplatinDrug
Also called None specified
Carboplatin will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy.
Carboplatin will be given once every three weeks as a 30-minute intravenous infusion immediately following the infusion of docetaxel. Patients will receive two cycles of consolidation treatment.
DocetaxelDrug
Also called Taxotere
Docetaxel will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy.
Docetaxel will be given once every three weeks administered as a one-hour IV infusion. Patients will receive two cycles of consolidation treatment (1 cycle = 3 weeks).
radiation therapyRadiation
Also called none specified
Radiotherapy will be administered daily X 5 day/week for 34 days beginning on Day 1 of the study. Radiotherapy will follow immediately after the infusions of docetaxel and carboplatin.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Intervention | Experimental | Not described Receives: Drug: Carboplatin; Drug: Docetaxel; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Months from on-study to expired/last date known alive.
Measured: 14.95 months (average duration, on study date to off-study date)
Secondary outcomes (3)
Overall Response Rate
Patient response to treatment per RECIST:
Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
Measured: on-study date to date of best response
Time to Disease Progression
Time to disease progression in months
Measured: on-study date to date of progression
Number of Participants With Adverse Events by Grade
Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event with 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, and 5 = death related to adverse event
Measured: 30 days after last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startFeb 2004
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Treatment became standard.
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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Vicki Keedy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Vicki Keedy, MD, Study director, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664105
- Sponsor's protocol ID
- VICC THO 0319
- Other IDs
- VU-VICC-THO-0319, VU-VICC-030269
- Status last verified
- Aug 2012
- First submitted
- 19 Apr 2008
- Last updated
- 7 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhII Study of Concurrent Chemoradiotherapy With Weekly Docetaxel, Carboplatin and Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel and Carboplatin for Locally Advanced Inoperable Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00664105
- Acronym / sponsor ID
- VICC THO 0319
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Treatment became standard.
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Posted 22 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of docetaxel as a multimodality regimen in this patient population. Docetaxel at a dose of 20 mg/m2 appears to be a well-tolerated "weekly" dose when combined with either cisplatin 25 mg/m2 20-22 or carboplatin area under the curve (AUC) 2 23-25 concomitant with radiation therapy.
PURPOSE: To explore the potential benefits of the radiosensitizing effects of weekly docetaxel/carboplatin/radio therapy concurrent therapy followed full dose systemic docetaxel/carboplatin consolidation therapy on overall response rate, survival, progression-free survival, safety and toxicity in patients with locally advanced NSCLC.
Detailed description
OBJECTIVES:
Primary
- To determine the overall survival (0S) for advanced NSCLC patients receiving concurrent chemoradiotherapy with weekly docetaxel, carboplatin and radiation therapy followed by two cycles of consolidation chemotherapy with docetaxel and carboplatin.
Secondary
- To determine the overall response rate in patients treated with this regimen.
- To determine the time to disease progression in patients treated with this regimen.
- To assess the safety and tolerability of this regimen in these patients.
OUTLINE:
- This is a Phase II, open label, multi-center study to determine the overall survival rate for patients treated with concurrent chemoradiotherapy with weekly docetaxel, carboplatin and radiation followed by two cycles of consolidation chemotherapy with docetaxel and carboplatin. Eligible patients will receive concurrent therapy with docetaxel (20 mg/m2) administered weekly for seven weeks as a 30-minute intra-venous (IV) infusion followed by carboplatin (AUC 2) administered weekly for seven weeks as a 30-minute IV infusion. Concurrent radiation therapy will be administered at a dose of 1.8 Gy daily 5 days/week for 25 fractions followed by a dose of 2.0 Gy daily, 5 days/week for 9 fractions (total of 34 fractions). There will be a three-week rest period following the end of the concurrent chemotherapy after which the consolidation phase will begin. During this phase of the study, patients will be treated with docetaxel (75 mg/m2) administered as a 1-hour IV infusion followed by carboplatin (AUC 6) administered as a 30-minute IV infusion. Patient will be treated every three weeks for a total of two cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Intervention | Experimental | Drug: Carboplatin, Drug: Docetaxel, Radiation: radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients must voluntarily sign and date an informed consent before the initiation of any study procedures
- Patients must have non-metastatic, inoperable, Stage IIIA or IIIB histologically or cytologically documented NSCLC without evidence of malignant pleural effusion
- Patients must not have received any prior systemic chemotherapy, thoracic radiotherapy or surgical resection for treatment of NSCLC
- Patients must have at least one site of unidirectionally measurable disease
- Patients must be ≥ 3 weeks from a formal exploratory thoracotomy
Key exclusion criteria (7 listed)
- Known hypersensitivity to drugs formulated with polysorbate 80
- Peripheral neuropathy Grade ≥ 2.
- Wet stage IIIB (documented malignant pleural effusion) or stage IV NSCLC
- Previous chemotherapy or radiation therapy
- Any concomitant malignancy, brain metastasis or uncontrolled, clinically significant medical or psychiatric disorder
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 |
|---|---|---|
| CarboplatinAlso: None specifiedCarboplatin will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy. Carboplatin will be given once every three weeks as a 30-minute intravenous infusion immediately following the infusion of docetaxel. Patients will receive two cycles of consolidation treatment. | Drug | Therapeutic Intervention |
| DocetaxelAlso: TaxotereDocetaxel will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy. Docetaxel will be given once every three weeks administered as a one-hour IV infusion. Patients will receive two cycles of consolidation treatment (1 cycle = 3 weeks). | Drug | Therapeutic Intervention |
| radiation therapyAlso: none specifiedRadiotherapy will be administered daily X 5 day/week for 34 days beginning on Day 1 of the study. Radiotherapy will follow immediately after the infusions of docetaxel and carboplatin. | Radiation | Therapeutic Intervention |
Primary outcome
Overall Survival
Time frame: 14.95 months (average duration, on study date to off-study date)
Months from on-study to expired/last date known alive.
3 secondary outcomes
Overall Response Rate
Time frame: on-study date to date of best response
Time to Disease Progression
Time frame: on-study date to date of progression
Number of Participants With Adverse Events by Grade
Time frame: 30 days after last treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
- 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.
Vicki Keedy, MD study director
Vanderbilt-Ingram Cancer Center
15 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 Carboplatin, Docetaxel and radiation therapy in people with Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 15 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?
The sponsor lists 18 inclusion and 7 exclusion criteria. 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 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 22 Mar 2011). 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 Survival (time frame: 14.95 months (average duration, on study date to off-study date)). 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 7 Sep 2012.