Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)

This study has been terminated.
(Treatment became standard.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Vicki Keedy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00664105
First received: April 19, 2008
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: Carboplatin
Drug: Docetaxel
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 14.95 months (average duration, on study date to off-study date) ] [ Designated as safety issue: No ]
    Months from on-study to expired/last date known alive.


Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: on-study date to date of best response ] [ Designated as safety issue: No ]

    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


  • Time to Disease Progression [ Time Frame: on-study date to date of progression ] [ Designated as safety issue: No ]
    Time to disease progression in months

  • Number of Participants With Adverse Events by Grade [ Time Frame: 30 days after last treatment. ] [ Designated as safety issue: Yes ]
    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


Enrollment: 63
Study Start Date: February 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapeutic Intervention Drug: Carboplatin

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.

Other Name: None specified
Drug: Docetaxel

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).

Other Name: Taxotere
Radiation: radiation therapy
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.
Other Name: none specified

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664105

Locations
United States, Florida
M.D. Anderson Cancer Center, Orlando
Orlando, Florida, United States, 32806
United States, Maryland
Chesapeake Oncology Hematology Associates
Baltimore, Maryland, United States, 21225
United States, Ohio
University Hospital of Cleveland
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center
Allentown, Pennsylvania, United States, 18103
United States, Tennessee
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
Clarksville Regional Hematology Oncology Group
Clarksville, Tennessee, United States, 37043
Jackson Madison County Hospital
Jackson, Tennessee, United States, 38301
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37920
The West Clinic, PC
Memphis, Tennessee, United States, 38120
St. Thomas Health Services
Nashville, Tennessee, United States, 37205
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Meharry Medical College
Nashville, Tennessee, United States, 37208
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Director: Vicki Keedy, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Vicki Keedy, MD, Assistant Professor of Medicine; Clinical Director, Sarcoma Program; Assistant Medical Director, Clinical Trials Shared Resource; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00664105     History of Changes
Other Study ID Numbers: VICC THO 0319, VU-VICC-THO-0319, VU-VICC-030269
Study First Received: April 19, 2008
Results First Received: September 30, 2010
Last Updated: August 30, 2012
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014