Carboplatin, Paclitaxel, Bevacizumab and Vorinostat for Patients With Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT00702572
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Vorinostat, Bevacizumab, Carboplatin, Paclitaxel — DRUG
    This dose escalating phase will enroll sequential cohorts of 3-6 patients to be entered at the following dose levels: Level -1: Days 1-14, Vorinostat 100 mg po QD; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 175 mg/m2. Level 1: Days 1-14, Vorinostat 200 mg po QD days 1-14; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 200 mg/m2. Level 2: Days 1-14, Vorinostat 300 mg po QD days 1-14; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 200 mg/m2. Level 3: Days 1-14, Vorinostat 400 mg po QD days 1-14; Day 3, Bevacizumab 15 mg/kg; Carboplatin 6 AUC; Paclitaxel 200 mg/m2. Treatment cycles will be repeated every 3 weeks. The highest dose level which \<2 out of 5 patients experience dose limiting toxicity will be defined as the recommended phase II dose.
  • Vorinostat, Bevacizumab, Carboplatin, Paclitaxel — DRUG
    Once the recommended phase II dose has been established from Phase I, 12 additional patients will be treated to evaluate the toxicities and safety profile of the 4-drug regimen.

Study Details

The primary objective of the study is to establish the phase II recommended dose of Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lunc cancer.

Key Dates

Start date
Apr 30, 2008
Status verified
Sep 2016
Primary completion
May 31, 2016
Completion
Sep 30, 2016

Study Design

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

Arms

  • Experimental: 1
    Phase I dose escalating scheme
  • Experimental: 2
    Phase 2 will evaluate the toxicities and safety profile of the 4-drug regimen.

Primary Outcome Measure

Establish the phase II recommended dose (P2RD) of Vorinostat when administered in combination with the regimen of carboplatin, paclitaxel and bevacizumab for patients with previously untreated advanced non-small cell lung cancer. [ Time Frame: An average of 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State College of Medicine, Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033-

Find similar trials in Hershey, PA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center· Hershey, PA

Related Studies