MDACC Study Summary 2005-0091 (Archived)

Study Summary
No. 2005-0091:.......Phase I Studies......Razelle Kurzrock......Phase I Program

Study Summary Title



Study Summary Number:	2005-0091

Study Title:	Phase 1 Open-Label, Dose Escalating, Multiple Dose Study To Determine The Safety, Tolerability, Maximum Tolerated Dose, And Pharmacokinetics Of MPC-6827 Administered IV Weekly X 3, Repeated Every 28 Days, In Subjects With Refractory Solid Tumors

Physician

New Patient Referral



Name:	Razelle Kurzrock	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Phase I Program	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-1290 Contact us about clinical trials

General Information



Disease Group:	Phase I Studies	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	weekly return visits are required

Treatment Agents:	MPC-6827	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Patients will be required to have approximately a 24 hour admission on days 1, 8 and 15 of cycle one. If the patient (at the discretion of the PI) requires admission for subsequent dosing they will be inpatient for approx. 24 hours after each dose.


Description/ Intervention:	The goal of this clinical research study is to evaluate the safety and tolerability of the drug MPC-6827 when given as a 2-hour infusion by vein to patients with advanced cancer. Researchers want to find the highest safe dose of MPC-6827 that can be given. Researchers also want to study the levels of MPC-6827 in the blood and urine after receiving a 2-hour infusion.

Study Objectives / Outcomes

Primary:
· To investigate the safety and tolerability of MPC-6827 administered as a 2-hour intravenous (IV) infusion, given once weekly for 3 consecutive weeks, repeated every 28 days in subjects with a variety of refractory solid tumors;
· To establish the maximum tolerated dose (MTD) of MPC-6827 as a single agent in this subject population;
· To characterize the pharmacokinetics (PK) of MPC-6827 administered as a 2 hour IV infusion.

Secondary:
· To observe for any evidence of antitumor activity of MPC-6827 in treatment of a variety of refractory solid tumors.

Additional Observations:
· Measurement of tumor biomarkers, where appropriate.
· Measurement of microtubule disruption in peripheral blood white blood cells (WBC).

Study Status Information



Study Activation / Registration Date:	03/16/2005

IRB Review and Approval Date:	03/07/2005

Study Type:	Phase I

Recruitment Status:	Terminated

Projected Accrual:	up to 118

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) Capable of understanding the informed consent and complying with the protocol. Patients must sign the consent prior to the performance of any study related procedures

2) Advanced or metastatic cancer which has progressed despite prior treatment with the current standard of care

3) Documented pathologic evidence of malignancy

4) Measurable or evaluable neoplastic disease

5) Age greater than or equal to 18 years

6) Karnofsky score of greater than or equal to 70

7) Predicted life expantancy of greater than or equal to 12 weeks

8) Have adequate hematology and organ function defined by: Liver function tests (AST & ALT) less than or equal to 3 X ULN; Bilirubin less than or equal to ULN; Neutrophil count greater than or equal to 1,500/mm^3 and Platelets greater than or equal to 100,000/mm^3; Serum creatinine less than or equal to 1.5 x ULN; Hemoglobin greater than or equal to 9.0 g/dL

9) Recovered or stablilized from clinically significant toxicities of prior chemotherapy , surgery or radiotherapy

10) No baseline peripheral or central neuropathy above Grade 1

Exclusion Criteria:

1) Prior serious, uncontrolled hypersensitivity reaction to Cremophor® EL

2) Pregnant or lactating (women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment). Male and female subjects of childbearing potential must use appropriate birth control (abstinence, barrier methods, oral contraceptives and/or intrauterine devices) during the entire duration of the study, or the subject must be surgically sterile (with documentation in the subject's medical records). Males must use effective contraception for at least 3 months following the last dose of MPC-6827.

3) Any other anticancer treatment or investigational therapy within 28 days prior to study Day 1 or within 6 weeks after mitomycin C or nitrosourea. Subjects with advanced prostate cancer may continue to receive leuteinizing hormone- releasing hormone (LHRH) therapy while in this study. Subjects with breast cancer may continue to receive Herceptin® for systemic control.

4) Spinal cord compression

5) History of another malignancy within the last 5 years (except nonmelanomatous skin carcinoma or cervical carcinoma in situ)

6) Pre-existing dementia/cognitive dysfunction

7) Require Neupogen® or Neulasta® to maintain neutrophil count at study entry

8) Have primary brain cancer

9) Have history of ischemic heart disease

10) Have diabetes

Links

Registration Number: NCT00394446
Study Information on Clinical Trials Registry (clinicaltrials.gov)