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Carboplatin, Irinotecan, and Radiation Therapy Followed By Docetaxel in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00449020
First received: March 15, 2007
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin, irinotecan, and docetaxel, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin and irinotecan together with radiation therapy followed by docetaxel works in treating patients with newly diagnosed stage III non-small cell lung cancer.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Carboplatin and Irinotecan Concomitantly With Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel for Locally Advanced Non-Small Cell Lung Cancer (GIA 12177).

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • Response (complete response, partial response, overall response) as measured by RECIST criteria prior to course 1 and within 1 month after completion of course 3 of consolidation chemotherapy [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity/safety profile as measured by NCI CTCAE v 3.0 [ Time Frame: 5.25 years ] [ Designated as safety issue: Yes ]
  • Median survival [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]
  • 1-year survival [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]
  • 2-year survival [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2004
Study Completion Date: January 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Carboplatin
    CARBOPLATIN (AUC=2) IV in 250 cc NS over 30 minutes, weekly for seven weeks (Days #1, #8, #15, #22, #29, #36 and #43) along with radiation.
    Drug: Docetaxel
    DOCETAXEL 75 mg/m2 IV over one hour every three weeks for 3 cycles.
    Drug: irinotecan hydrochloride
    IRINOTECAN 30 mg/m2 IV over 90 minutes weekly for seven weeks (Days #1, #8, #15, #22, #29, #36 and #43) along with radiation.
    Radiation: radiation therapy
    Radiotherapy will start on the first day of scheduled chemotherapy. The daily administered dose will be 1.8 Gy, 5 days a week for 4.4 weeks, 22 fractions, ( 39.6 Gy) to the primary tumor and mediastinum (primary planning target volume: PPTV). After 39.6 Gy, the same targets will be treated by oblique fields at 1.8 GY for 3 fxs to a toal dose of 45 GY. Thereafter, the primary tumor and involved nodal metastasis (secondary planning target volume SPTV) will be boosted at 2 Gy per day to 18 Gy in 9 fractions. The total dose will be 63 Gy in 35 fractions over seven weeks.
Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with newly diagnosed stage IIIA or IIIB non-small cell lung cancer treated with concurrent carboplatin, irinotecan hydrochloride, and radiotherapy followed by consolidation docetaxel.

Secondary

  • Evaluate the safety, toxicity, and complications of this regimen in these patients.
  • Evaluate the median survival, 1-year and 2-year survival, and time to tumor progression in these patients.

OUTLINE:

  • Chemoradiotherapy: Patients receive carboplatin IV over 30 minutes followed by irinotecan hydrochloride IV over 90 minutes on day 1. Patients also undergo radiotherapy once daily on days 1-5. Treatment repeats weekly for up to 7 courses in the absence of disease progression or unacceptable toxicity.
  • Consolidation chemotherapy: Beginning 3-4 weeks after completion of chemoradiotherapy, patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Stage IIIA or IIIB disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan
  • No clinically significant malignant pleural or pericardial effusion (i.e., stage IIIB wet disease)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Absolute neutrophil count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin ≥ 8.0 g/dL
  • Bilirubin normal

  • Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:

    • AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
    • AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
    • AP ≤ 5 times ULN AND AST or ALT normal
  • Creatinine < 2.0 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • No New York Heart Association class III-IV heart disease
  • No history of serious cardiac disease not adequately controlled
  • No documented myocardial infarction within the past 6 months
  • No congestive heart failure
  • No unstable angina
  • No clinically significant arrhythmia
  • No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
  • No peripheral neuropathy > grade 1
  • No other malignancy within the past 5 years other than skin cancer

PRIOR CONCURRENT THERAPY:

  • More than 3 weeks since prior major surgery
  • No prior systemic chemotherapy, thoracic radiotherapy, or surgical resection for NSCLC
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449020

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Luis E. Raez, MD, FACP University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00449020     History of Changes
Other Study ID Numbers: EPROST-20030244, SCCC-2003049, WIRB-20051708
Study First Received: March 15, 2007
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Irinotecan
Docetaxel
 Carboplatin
Camptothecin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013