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Phase I Abraxane Weekly and Three Weekly Schedule With Vandetanib

NCT00667147 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2014-11-19

No results posted yet for this study

Summary

This study uses the drugs Abraxane (also called ABI-007) and Vandetanib (also called Zactima and ZD6474). Abraxane has been approved by the Food and Drug Administration (FDA), for the treatment of breast cancer. Vandetanib is an experimental drug and has not been approved by the FDA for the treatment of any condition. Vandetanib has shrunk some non-small cell lung cancer, prostate cancer and thyroid cancer in some studies in humans. This combination of drugs is not approved for the treatment of any condition by the FDA.

This study is being done in two phases. The first phase of the trial has two main objectives: 1) To find the highest daily dose of vandetanib that can be given safely with once weekly Abraxane and 2) To find the highest daily dose of vandetanib that can be given safely with Abraxane given every three weeks. Participants will be randomly assigned (like flipping a coin) to receive Abraxane weekly (Arm A) or once every three weeks (Arm B). The dose of Abraxane given will remain the same for the whole study - 100 mg/m2 when given weekly and 260 mg/m2 when given every three weeks. Participants will be entered onto each arm of the study in groups of three, and higher doses of vandetanib will be given each group of participants. The increase of vandetanib will stop once more than one participant has serious side effects. The highest dose of vandetanib that can be given with Abraxane (without serious side effects) in each Arm will be called the pilot dose.

In the second phase of the study twenty participants will be randomly assigned to Arm A or Arm B and receive the pilot dose of vandetanib that was reached in the first phase of the study. The purpose of the second phase of the study is to see how many tumors shrink when participants receive the pilot dose of the drug combination on each Arm, as well as to gather more information about the side effects.

Conditions

Interventions

DRUG

Weekly Abraxane and Daily Vandetanib

Abraxane once a week for three weeks, followed by one week with no Abraxane. Vandetanib once a day every day for 28 days. This four week period is called a cycle.

DRUG

Abraxane every three weeks and daily vandetanib

Abraxane on day one of study therapy, followed by 20 days of no Abraxane. Vandetanib once a day every day for 21 days. This three week period is called a cycle.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Celgene Corporation

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Principal Investigators

  • Anthony El-Khoueiry, M.D. · U.S.C. / Norris Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2012-05-31
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00667147 on ClinicalTrials.gov