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Study Summary
No. 2003-1002:.......Phase I Studies......Gerald Falchook......Investigational Cancer Therapeutics
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Study Summary Title
Study Summary
Number:
2003-1002
Study Title:Phase I Study of a Combination of Doxil, VELCADE, and Gemcitabine in Advanced Cancer
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Physician New Patient Referral
Name:Gerald FalchookPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Investigational Cancer TherapeuticsReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-9669
Contact us about clinical trials
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General Information
Disease Group:Phase I StudiesSupported By:N/A
Phase of Study:Phase IReturn
Visit:
Patients must return to MDACC about every 3 weeks.
Treatment
Agents:
Doxil
Gemcitabine
Velcade
Home Care:The initial or loading doses of all drugs will be given in the clinic.
Subsequent doses may be given by the patient's local physician.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
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.
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Study Objectives / Outcomes
Primary
To determine the maximum tolerated dose of a combination of Doxil, gemcitabine and PS341 (Velcade).
To determine the qualitative and quantitative toxicity and safety of this combination.
Secondary
To document in a descriptive fashion responses to this combination.
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Study Status Information
Study Activation / Registration Date:01/18/2005
IRB Review and Approval Date:05/05/2004
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:276
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 (ANC > 1,500 and Plt > 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%, SGPT < 5x 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 CHF

10) Female subject is either post-menopausal or surgically sterilized or willing to use an aceptable 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/m2. Total cumulative dose of doxorubicin plus Doxil should not exceed 550 mg/m2 (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.

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Links
Registration Number: NCT00500422
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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