Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500422
Status:
COMPLETED
Last Update Posted:
2013-02-13
First Post:
2007-07-10
Brief Title:
Doxil Gemcitabine and Velcade PS341 in Advanced Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of a Combination of Doxil Velcade and Gemcitabine in Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to find the highest safe dose of the drug Velcade bortezomib that can be given together with gemcitabine and pegylated liposomal doxorubicin Doxil in the treatment of advanced cancer The effect of this combination treatment on tumor growth will also be studied
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None