Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT00004093
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • carboplatin — DRUG
    Carboplatin will be dosed at a target AUC of 5, and will be given on day 1 of each cycle
  • Gemcitabine — DRUG
    Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of each 21-day cycle of induction chemo (following carboplatin on day 1).
  • paclitaxel — DRUG
    Paclitaxel will be given on day 1 of each week for 6 weeks at a dose of 50 mg/m2.
  • vinorelbine — DRUG
    Vinorelbine will be given on day 1 of each week for 6 weeks at a starting dose of 10 mg/m2, escalating up to 15 mg/m2 if no dose limiting toxicities are observed.
  • radiation therapy — RADIATION
    Radiation will be given at a dose ranging between 45 to 66 Gy, depending on patient-specific characteristics.
  • Navelbine — DRUG
    Navelbine will be administered at a dose of 10-15 mg/m2 in 100 cc NS to be administered over 10 minutes I.V. (one dose weekly during radiation therapy)
  • Taxol — DRUG
    Taxol will be administered at a dose of 50 mg/m2 in 250 cc of NS or D5W over 60 minutes, following Navelbine (one dose weekly during radiation therapy)

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage III non-small cell lung cancer.

Key Dates

Start date
Aug 31, 1999
Status verified
May 2012
Primary completion
Feb 28, 2002
Completion
Mar 31, 2002

Study Design

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

Primary Outcome Measure

Maximum tolerated dose of the combination therapies [ Time Frame: After each cycle of therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicagoIllinois60611-3013-

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