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

NCT ID: NCT00449020

Last Updated: 2016-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2008-01-31

Brief Summary

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.

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.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Docetaxel

DOCETAXEL 75 mg/m2 IV over one hour every three weeks for 3 cycles.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis E. Raez, MD, FACP

Role: STUDY_CHAIR

University of Miami Sylvester Comprehensive Cancer Center

Locations

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Countries

United States

References

Bastos BR, Hatoum GF, Walker GR, Tolba K, Takita C, Gomez J, Santos ES, Lopes G, Raez LE. Efficacy and toxicity of chemoradiotherapy with carboplatin and irinotecan followed by consolidation docetaxel for unresectable stage III non-small cell lung cancer. J Thorac Oncol. 2010 Apr;5(4):533-9. doi: 10.1097/JTO.0b013e3181ce3e00.

Reference Type: RESULT

PMID: 20357618 (View on PubMed)

Other Identifiers

SCCC-2003049

Identifier Type: OTHER

Identifier Source: secondary_id

WIRB-20051708

Identifier Type: OTHER

Identifier Source: secondary_id

20030244

Identifier Type: -

Identifier Source: org_study_id