A Study to Evaluate the Effectiveness of 5-Azacitidine and Bevacizumab in Advanced Renal Cell Carcinoma

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT00934440
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    * First treatment: 10 milligram per kilograms (MG/KG) intravenously (IV) on Day 1every two weeks over 90 minutes. * Second treatment: 10 MG/KG IV on Day 1 every two weeks over 60 minutes. * Third and subsequent treatments: 10 MG/KG IV on Day 1 every two weeks over 30 minutes (minimum of two cycles).
  • Azacitidine — DRUG
    * Dose level 1: 35 mg/m2/day for 7 days. * Dose level 2: 55 mg/m2/day for 7 days. * Dose level 3: 75 mg/m2/day for 7 days. * mg/m2/day = dose based on height and weight

Study Details

To identify the maximum tolerable dose and assess qualitative/quantitative toxicities in patients with advanced renal cell cancer treated with combination of 5-azacitidine and bevacizumab.

Key Dates

First listed
Jul 8, 2009
Start date
Jun 30, 2009
Status verified
May 2017
Primary completion
Nov 30, 2015
Completion
Nov 30, 2015

Study Design

Enrollment
11 participants (actual)
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: 5-azacitidine
    A traditional 3+3 dose escalation trial was implemented. Successive cohorts of patients (3 participants/cohort) received bevacizumab at the standard dose of 10mg/kg in combination with escalating doses of 5-azacitidine. If no dose limiting toxicity (DLT) is seen, subsequent patients will be treated at the next dose level. If one DLT is seen, an additional three patients will be accrued at that dose level. If two or more DLTs are seen at one dose level, then the previous dose level will be chosen for phase IIA. If two DLT's are seen at dose level 1, the trial will end. The standard 5-azacitidine dose is 75mg/m2/day for 7 days. If no DLT is seen at dose level 3, then we will proceed with the phase IIA portion of the study.

Primary Outcome Measure

Toxicities by Dose Level [ Time Frame: 3 to 6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160-
Stormont-Vail Cotton O'Neil Cancer CenterTopekaKansas66606-

Find similar trials in Kansas City, KS

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
University of Kansas Medical Center· Kansas City, KSStormont-Vail Cotton O'Neil Cancer Center· Topeka, KS

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