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

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT00449020
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    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.
  • Docetaxel — DRUG
    DOCETAXEL 75 mg/m2 IV over one hour every three weeks for 3 cycles.
  • irinotecan hydrochloride — DRUG
    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 therapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Jan 31, 2004
Status verified
Dec 2016
Primary completion
May 31, 2007
Completion
Jan 31, 2008

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136-

Find similar trials in Miami, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Miami Sylvester Comprehensive Cancer Center· Miami, FL

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