Phase I Study of a Combination of Doxil, Velcade, and Gemcitabine in Advanced Cancer
Pegylated liposomal doxorubicin is a newer form of the common anticancer drug Adriamycin.
It is enclosed in liposomes, which are fat particles found normally in the body. This new
form is designed to act against cancer cells while causing less damage to normal tissue.
Gemcitabine is a drug that has shown to be active in patients with several different cancers
including pancreatic cancer, breast cancer, and certain lymphomas. Bortezomib is a new drug
that is designed to block the proteins needed for tumor growth.
Groups of 3 participants that are less than 65 years old and 3-6 participants that are at
least 65 years old will be enrolled at a time. Each new group will receive a higher dose
level than the group before as long as no serious side effects occur.
Once the highest tolerable dose is determined, up to 30 additional patients with small cell
cancer or neuroendocrine carcinoma, and up to 30 patients with T cell lymphoma will be
treated at that dose.
All participants will receive pegylated liposomal doxorubicin through a vein over about 2
hours. The drug will be given once every 21 days (3 weeks or 1 cycle). Gemcitabine will be
given through a vein over 30 minutes on Days 1 and 8 every 21 days. Patients will only
receive the combination of both drugs on Day 1; on that day pegylated liposomal doxorubicin
will be given before the dose of gemcitabine. Bortezomib will be given by vein on Days 1,
4, 8 and 11 of every 21 days, except for the first group of patients who will receive it on
days 1 and 8 only. Participants whose tumors are responding to treatment may continue
treatment if their doctor approves for as long as they respond, as long as there are no
serious side effects.
Because of a nationwide shortage of pegylated liposomal doxorubicin, you may continue
treatment with gemcitabine and bortezomib. If pegylated liposomal doxorubicin becomes
available, you may be able to receive it again.
During the study, you will have a weekly blood test (about 2 tablespoons of blood) and a
physical exam. X-rays and other scans, such as MRIs and CT scans, will be done at 6 weeks
to measure the size of the tumor. Other tests will be done if needed.
The treatment will be stopped if the cancer grows or if severe side effects occur, and other
treatments may be offered.
This is an investigational study. All three drugs are approved by the FDA for use against
some kinds of cancer. Their use in this study is investigational. Up to 276 patients will
take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
Dose limiting toxicity assessed during first course (21 days).
Gerald Falchook, MD,MS
UT MD Anderson Cancer Center
United States: Institutional Review Board
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