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Phase I Study of a Combination of Doxil, Velcade, and Gemcitabine in Advanced Cancer

Phase 1
Not Enrolling
Solid Tumors

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Trial Information

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.

Inclusion Criteria:

1. All patients with histologic proof of advanced cancer, who are not candidates for
known regimens or protocol treatments of higher efficacy or priority or who have no
therapy that increases survival by at least 3 months, shall be eligible for this
study unless the standard therapy includes one or more of the drugs in this protocol.

2. Estimated life expectancy of at least 12 weeks. (Performance status of less than or
equal to 2 (Zubrod scale).

3. Patients must voluntarily sign an informed consent indicating that they are aware of
the investigational nature of this study in keeping with the policies of the
hospital. The only acceptable consent form is the one attached at the end of this

4. Evaluable disease

5. Patients must have been off all previous chemotherapy or radiotherapy for at least 3
weeks and off all targeted biologic therapies for at least 5 half-lives, whichever is
shorter, prior to entering this study. Patients may receive localized palliative
radiotherapy immediately before or during treatment.

6. Adequate bone marrow function (Absolute neutrophil count (ANC) > 1,500 and Platelet >
100,000) except in the post-transplant arm where the hematologic minimum requirements
will not apply if there is disease infiltration of the bone marrow.

7. Adequate liver function (bilirubin of less than or equal to 1.5 mg%, alanine
aminotransferase (SGPT) < 5 times normal)

8. Adequate renal function (creatinine less than or equal to 1.5 mg%).

9. Cardiac ejection fraction greater than or equal to 50% without evidence of Congestive
heart failure (CHF)

10. Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study.

11. Male subject agrees to use an acceptable methods for contraception of the duration of
the study.

Exclusion Criteria:

1. Symptomatic brain metastases requiring concurrent treatment, inclusive of but not
limited to, surgery, radiation or cortico steroids.

2. Need for concurrent radiotherapy or other chemotherapy (other than localized
palliative radiotherapy)

3. New York Heart Association Class > II

4. Diagnosis of leukemia or myelodysplastic syndrome

5. Prior cumulative doxorubicin dose > 300 mg/m^2. Total cumulative dose of doxorubicin
plus Doxil should not exceed 550 mg/m^2 (or 400 mg/m)

6. Pregnant or lactating women. Confirmation that the subject is not pregnant must be
established by a negative serum beta-human chorionic gonadotropin (beta-hCG)
pregnancy test result obtained during screening.

7. Patient has greater than or equal to Grade 2 peripheral neuropathy within 14 days
before enrollment

8. Concurrent uncontrolled infection requiring intravenous antibiotics

9. Patient has hypersensitivity to bortezomib, boron, mannitol, doxorubicin, or

10. Patient has received other investigational drugs within 14 days before enrollment.

11. Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Time Frame:

Dose limiting toxicity assessed during first course (21 days).

Safety Issue:


Principal Investigator

Gerald Falchook, MD,MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2005

Completion Date:

November 2012

Related Keywords:

  • Solid Tumors
  • Solid Tumors
  • Doxil
  • Adriamycin
  • Pegylated Liposomal Doxorubicin
  • Liposomal Doxorubicin
  • Doxorubicin Hydrochloride
  • Gemcitabine
  • Gemzar
  • Bortezomib
  • Velcade
  • PS341
  • PS-341
  • LDP-341
  • MLN341



UT MD Anderson Cancer Center Houston, Texas  77030