Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00616785
First received: February 14, 2008
Last updated: February 6, 2009
Last verified: September 2008
  Purpose

RATIONALE: Drugs used in chemotherapy, such as irinotecan, cisplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Drug: irinotecan hydrochloride
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Irinotecan and Cisplatin Induction Chemotherapy Followed by Radiotherapy Concurrently With Etoposide/Cisplatin in Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of local/regional control [ Designated as safety issue: No ]
  • Rate of systemic disease control [ Designated as safety issue: No ]
  • Feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity of irinotecan hydrochloride and cisplatin induction chemotherapy as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: June 2007
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the efficacy of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in patients with locally advanced, unresectable stage III non-small cell lung cancer.
  • To evaluate the feasibility of radiotherapy administered concurrently with etoposide and cisplatin chemotherapy after induction chemotherapy in these patients.

Secondary

  • To evaluate the toxicity of induction chemotherapy comprising irinotecan hydrochloride and cisplatin in these patients.
  • To assess whether this induction chemotherapy regimen will improve patient survival when compared with outcomes from the predecessor study, SWOG-9019.

OUTLINE: Patients receive dose-dense induction chemotherapy comprising irinotecan hydrochloride IV and cisplatin IV on days 1 and 8. Treatment repeats every 21 days for up to 2 courses.

After completion of induction chemotherapy, patients undergo radiotherapy five days a week for approximately 7 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and 29-33.

After completion of study therapy, patients are followed at 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

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

    • Stage IIIA (N2) or IIIB disease

      • Pathologic documentation of N2-3 mediastinal lymph nodes is encouraged but not required if nodal size is ≥ 1.5 cm in largest diameter
      • No stage IIIB disease with malignant pleural effusion or superior sulcus tumor
  • At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors
  • Unresectable disease
  • No known brain metastasis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm³
  • Hemoglobin ≥ 9.0 g/dL (can be corrected by transfusion)
  • Platelet count ≥ 100,000/mm³
  • Creatinine < 1.5 mg/dL
  • Total bilirubin < 2 times upper limit of normal (ULN)
  • Transaminases < 3 times ULN
  • Patient compliance and geographic proximity that allow adequate follow up
  • No serious, uncontrolled systemic intercurrent illness (e.g., infections or poorly controlled diabetes)
  • No history of significant neurological or mental disorder, including seizures or dementia
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
  • No active cardiac disease not controlled by therapy
  • No myocardial infarction within the past 12 months

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for NSCLC
  • No other concurrent systemic chemotherapy, investigational drug, or radiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616785

Locations
Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Joo-Hang Kim, MD    +82-10-4507-6063    kjhang@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
Study Chair: Joo-Hang Kim, MD Yonsei University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00616785     History of Changes
Other Study ID Numbers: CDR0000584442, YONSEI-4-2007-0120
Study First Received: February 14, 2008
Last Updated: February 6, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
Etoposide phosphate
Irinotecan
Cisplatin
Etoposide
Camptothecin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014