Clinical trial NCT00238615: Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC
Official title: A Phase II Trial of Concurrent Docetaxel (Taxotere) / Carboplatin / Radiotherapy Followed by Surgical Resection Followed by Consolidation Taxotere / Carboplatin in Stage III Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Carcinoma, Non-Small-Cell Lung
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
First posted: 2005-10-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.


Eligibility criteria: Inclusion Criteria:

Histologically confirmed stage IIIA or IIIB NSCLC

* Patients must have measurable disease
* No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC.
* Age\>18 years
* Life expectancy \>12 months
* ECOG performance status 0-1
* Normal organ and marrow function
* Medically fit for surgery at time of enrollment.
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment.
* Ability to understand and willingness to sign the consent form.

Exclusion Criteria:

* Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC.
* Patients receiving any other investigational agents.
* Known metastatic disease (brain or any other site)
* History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study.
* Peripheral neuropathy \>grade 1
* Uncontrolled concurrent illness
* Pregnant women
* Weight loss\>10% in the past 3 months before diagnosis.
* Hyperglycemia - exclusion from PET analysis
* HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.

Primary outcomes:
measure: 2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy.
timeFrame: Two years
Secondary outcomes:
measure: Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival
timeFrame: baseline, 5 weeks after combined chemo-radiation
Other outcomes:
measure: Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen
timeFrame: Specimen collected at time of surgery
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Heather A. Wakelee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kozak MM, Murphy JD, Schipper ML, Donington JS, Zhou L, Whyte RI, Shrager JB, Hoang CD, Bazan J, Maxim PG, Graves EE, Diehn M, Hara WY, Quon A, Le QT, Wakelee HA, Loo BW Jr. Tumor volume as a potential imaging-based risk-stratification factor in trimodality therapy for locally advanced non-small cell lung cancer. J Thorac Oncol. 2011 May;6(5):920-6. doi: 10.1097/jto.0b013e31821517db.
citation: Das M, Donington JS, Murphy J, Kozak M, Eclov N, Whyte RI, Hoang CD, Zhou L, Le QT, Loo BW, Wakelee H. Results from a single institution phase II trial of concurrent docetaxel/carboplatin/radiotherapy followed by surgical resection and consolidation docetaxel/carboplatin in stage III non-small-cell lung cancer. Clin Lung Cancer. 2011 Sep;12(5):280-5. doi: 10.1016/j.cllc.2011.06.003. Epub 2011 Jul 14.