Vinflunine and Erlotinib or Pemetrexed in Treating Patients With Unresectable or Metastatic Solid Tumors

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT00320073
Phase
PHASE1
Status
Completed

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Interventions

  • erlotinib hydrochloride — DRUG
    75 mg to 150mg
  • pemetrexed disodium — DRUG
    Pemetrexed is administered intravenously over 10 minutes, every 21 days
  • vinflunine — DRUG
    Vinflunine is administered intravenously over 20 minutes and should be given after pemetrexed, every 21 days

Study Details

RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib and pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vinflunine together with erlotinib or pemetrexed may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vinflunine when given together with erlotinib or pemetrexed in treating patients with unresectable or metastatic solid tumors.

Key Dates

First listed
May 3, 2006
Start date
Aug 31, 2006
Status verified
May 2012
Primary completion
Oct 31, 2008
Completion
Jan 31, 2010

Study Design

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

Arms

  • Experimental: Arm A
    Pemetrexed, Vinflunine, Folate, B12, Dexamethasone, Ondansetron, Midazolam
  • Experimental: Arm B
    Vinflunine, Erlotinib, Ondansetron, Midazolam

Primary Outcome Measure

Maximum tolerated dose (MTD) of vinflunine and pemetrexed disodium [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295-

Find similar trials in Chapel Hill, NC

By research site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill· Chapel Hill, NC

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