Irinotecan and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Part of paid clinical trials in Macon, Georgia.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT00639769
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • cisplatin — DRUG
    Starting dose 30 mg/m2 Dose level -1 20 mg/m2
  • irinotecan hydrochloride — DRUG
    50 mg/m2 IV over 60 minutes, plus Cisplatin 30mig/m2 IV, repeated weekly for two weeks. followed by a one-week rest. This 3-week schedule given two times to equal one 6-week cycle. Maximum of 6 cycles.

Study Details

RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, 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. PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.

Key Dates

Start date
Feb 28, 2002
Status verified
Sep 2012
Primary completion
May 31, 2007
Completion
Jul 31, 2008

Study Design

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

Arms

  • Experimental: Therapeutic Intervention

Primary Outcome Measure

Patient Response [ Time Frame: 6 weeks after last chemotherapy treatment ]

Locations (8)

FacilityCityStateZIPSite coordinators
Central Georgia Hematology Oncology Associates, P.C.MaconGeorgia--
Erlanger Health SystemChattanoogaTennessee--
Jackson-Madison County HospitalJacksonTennessee--
East Tennessee State UniversityJohnson CityTennessee--
Center for Biomedical ResearchKnoxvilleTennessee--
Meharry Medical CollegeNashvilleTennessee--
VA Tennessee Valley Healthcare CenterNashvilleTennessee--
Vanderbilt-Ingram Cancer CenterNashvilleTennessee--

Find similar trials in Macon, GA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Central Georgia Hematology Oncology Associates, P.C.· Macon, GAErlanger Health System· Chattanooga, TNJackson-Madison County Hospital· Jackson, TNEast Tennessee State University· Johnson City, TNCenter for Biomedical Research· Knoxville, TNMeharry Medical College· Nashville, TN

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