Doxil, Gemcitabine, and Velcade (PS341) in Advanced Cancer Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 18 February 2013
• Main ID: NCT00500422
• Date of registration: 10/07/2007
• Primary sponsor: M.D. Anderson Cancer Center
• Public title: Doxil, Gemcitabine, and Velcade (PS341) in Advanced Cancer Patients
• Scientific title: Phase I Study of a Combination of Doxil, Velcade, and Gemcitabine in Advanced Cancer
• Date of first enrolment: January 2005
• Target sample size: 134
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00500422
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Gerald Falchook, MD,MS
• Affiliation: UT MD Anderson Cancer Center

Key inclusion & exclusion criteria

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
protocol.

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
gemcitabine.

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.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Solid Tumors

Intervention(s)

Drug: Doxil

Drug: Gemcitabine

Drug: Velcade

Primary Outcome(s)

Maximum Tolerated Dose (MTD) [Time Frame: Dose limiting toxicity assessed during first course (21 days).]

Secondary ID(s)

2003-1002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors