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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

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Carboplatin

Docetaxel

irinotecan hydrochloride

radiation therapy

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Miami Sylvester Comprehensive Cancer Center

Outcomes

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

Secondary Outcome Measures

Toxicity/safety profile as measured by NCI CTCAE v 3.0

Median survival

1-year survival

2-year survival

Time to disease progression

Full Information

NCT ID

NCT00449020

First Posted

March 15, 2007

Last Updated

December 14, 2016

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT00449020

Brief Title

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

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).

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Miami

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

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

Intervention Name(s)

Docetaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

irinotecan hydrochloride

Intervention Description

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

Radiation

Intervention Name(s)

radiation therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Toxicity/safety profile as measured by NCI CTCAE v 3.0

Time Frame

5.25 years

Title

Median survival

Time Frame

5.25 years

Title

1-year survival

Time Frame

5.25 years

Title

2-year survival

Time Frame

5.25 years

Title

Time to disease progression

Time Frame

5.25 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis E. Raez, MD, FACP

Organizational Affiliation

University of Miami Sylvester Comprehensive Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

University of Miami Sylvester Comprehensive Cancer Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20357618

Citation

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.

Results Reference

result

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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

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