Clinical trial NCT00664105: Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-22
Enrollment: 63
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: 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall Survival
timeFrame: 14.95 months (average duration, on study date to off-study date)
Secondary outcomes:
measure: Overall Response Rate
timeFrame: on-study date to date of best response
measure: Time to Disease Progression
timeFrame: on-study date to date of progression
measure: Number of Participants With Adverse Events by Grade
timeFrame: 30 days after last treatment.
Other outcomes:
Locations:
city: Orlando
country: United States
facility: M.D. Anderson Cancer Center, Orlando
state: Florida
city: Baltimore
country: United States
facility: Chesapeake Oncology Hematology Associates
state: Maryland
city: Cleveland
country: United States
facility: University Hospital of Cleveland
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Clarksville
country: United States
facility: Clarksville Regional Hematology Oncology Group
state: Tennessee
city: Jackson
country: United States
facility: Jackson Madison County Hospital
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic, PC
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Health Services
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Vicki Keedy, MD
role: STUDY_DIRECTOR
References: