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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|ClinicalTrials.gov Identifier: NCT00449020|
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : December 15, 2016
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 or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: Carboplatin Drug: Docetaxel Drug: irinotecan hydrochloride Radiation: radiation therapy||Phase 2|
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2004|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||January 2008|
- 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.
- 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 ]
- Toxicity/safety profile as measured by NCI CTCAE v 3.0 [ Time Frame: 5.25 years ]
- Median survival [ Time Frame: 5.25 years ]
- 1-year survival [ Time Frame: 5.25 years ]
- 2-year survival [ Time Frame: 5.25 years ]
- Time to disease progression [ Time Frame: 5.25 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449020
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|Study Chair:||Luis E. Raez, MD, FACP||University of Miami Sylvester Comprehensive Cancer Center|