NCT00500422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

7.8 years

First QC Date

July 10, 2007

Last Update Submit

February 11, 2013

Conditions

Solid Tumors

Keywords

Solid TumorsDoxilAdriamycinPegylated Liposomal DoxorubicinLiposomal DoxorubicinDoxorubicin HydrochlorideGemcitabineGemzarBortezomibVelcadePS341PS-341LDP-341MLN341

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

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

Study Arms (1)

Doxil + Gemcitabine + Velcade

EXPERIMENTAL

Doxil Starting dose of 20 mg/m\^2 intravenous (IV) over 2 hours on Day 1 and Gemcitabine 500 mg/m\^2 IV over 30 minutes on Days 1 and 8; Velcade Starting dose of 0.7 mg/m\^2 IV on Days 1 and 8 of first 21 day cycle; increased dose of 1.0 to 1.3 on Days 1, 4, 8, and 11 of subsequent 21 day cycles.

Drug: DoxilDrug: GemcitabineDrug: Velcade

Interventions

DoxilDRUG

Starting dose of 20 mg/m\^2 IV over 2 hours on Day 1, 21 day cycle

Also known as: Pegylated Liposomal Doxorubicin, Adriamycin, Lipsomal Doxorubicin, Doxorubicin Hydrochloride
Doxil + Gemcitabine + Velcade
GemcitabineDRUG

500 mg/m\^2 IV over 30 minutes on Days 1 and 8, 21 day cycle

Also known as: Gemzar, Gemcitabine Hydrochloride
Doxil + Gemcitabine + Velcade
VelcadeDRUG

Starting dose of 0.7 mg/m\^2 IV on Days 1 and 8 of first 21 day cycle; increased dose of 1.0 to 1.3 on Days 1, 4, 8, and 11 of subsequent 21 day cycles

Also known as: Bortezomib, PS341, PS-341, LDP-341, MLN341
Doxil + Gemcitabine + Velcade

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Estimated life expectancy of at least 12 weeks. (Performance status of less than or equal to 2 (Zubrod scale).
  • 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.
  • Evaluable disease
  • 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.
  • 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.
  • Adequate liver function (bilirubin of less than or equal to 1.5 mg%, alanine aminotransferase (SGPT) \< 5 times normal)
  • Adequate renal function (creatinine less than or equal to 1.5 mg%).
  • Cardiac ejection fraction greater than or equal to 50% without evidence of Congestive heart failure (CHF)
  • 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.
  • Male subject agrees to use an acceptable methods for contraception of the duration of the study.

You may not qualify if:

  • Symptomatic brain metastases requiring concurrent treatment, inclusive of but not limited to, surgery, radiation or cortico steroids.
  • Need for concurrent radiotherapy or other chemotherapy (other than localized palliative radiotherapy)
  • New York Heart Association Class \> II
  • Diagnosis of leukemia or myelodysplastic syndrome
  • 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)
  • 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.
  • Patient has greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment
  • Concurrent uncontrolled infection requiring intravenous antibiotics
  • Patient has hypersensitivity to bortezomib, boron, mannitol, doxorubicin, or gemcitabine.
  • Patient has received other investigational drugs within 14 days before enrollment.
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

liposomal doxorubicinDoxorubicinGemcitabineBortezomib

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingBoronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsPyrazines

Study Officials

  • Gerald Falchook, MD,MS

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 12, 2007

Study Start

January 1, 2005

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

US(1)