AEG35156 and Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

July 27, 2006

Primary Completion Date

March 24, 2009

Study Completion Date

January 6, 2012

Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
DRUG

AEG35156

After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.

DRUG

docetaxel

After a recommended phase II dose (RPTD) of AEG35156 has been determined with docetaxel 75 mg/m2, patients will be accrued to the RPTD-1 plus docetaxel 100 mg/m2, and possibly RPTD plus docetaxel 100 mg/m2, to determine the RPTD of AEG35156 in combination with docetaxel 100 mg/m2 given every three weeks.

GENETIC

protein expression analysis

Cycle 1: Pre-dose on Days -2, 1, 8 and 15; repeat every 2-4 days if LFTs \> 5 x ULN1 Cycle 2: Prior to each infusion; repeat every 2-4 days if LFTs \> 5 x ULN1

GENETIC

reverse transcriptase-polymerase chain reaction

Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.

OTHER

flow cytometry

Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.

OTHER

immunoenzyme technique

Data will be summarized by descriptive statistics relevant to each of the proposed pharmacodynamic studies.

OTHER

immunohistochemistry staining method

The plasma concentration/ time data will be analysed using non-compartmental methods. The pharmacokinetic parameters to be determined for AEG35156 include the maximum observed plasma concentration (Cmax), the half-life (T1/2), and mean residence time (MRT).

OTHER

laboratory biomarker analysis

The plasma concentration/ time data will be analysed using non-compartmental methods. The pharmacokinetic parameters to be determined for AEG35156 include the maximum observed plasma concentration (Cmax), the half-life (T1/2), and mean residence time (MRT).

Trial Locations (3)

V5Z 4E6

BCCA - Vancouver Cancer Centre, Vancouver

M5G 2M9

Univ. Health Network-Princess Margaret Hospital, Toronto

H2W 1S6

McGill University - Dept. Oncology, Montreal

Sponsors
All Listed Sponsors
lead

NCIC Clinical Trials Group

NETWORK