AEG35156 and Docetaxel in Treating Patients With Solid Tumors

NCT00357747 | Completed Phase 1 DMC

• 3 other identifiers: I166CAN-NCIC-IND166CDR0000481440
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. AEG35156 may help docetaxel work better by making tumor cells more sensitive to the drug. PURPOSE: This phase I trial is studying the side effects and best dose of AEG35156 when given together with docetaxel in treating patients with solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (5)

• Safety and toxicity evaluated according to the NCI CTCAE version 3.0

  Every 3 weeks

• Response and progression using RECIST criteria

  Every 6 weeks

• Response duration measured from the time complete response or partial response (whichever is first recorded) is documented until the first date that recurrent or progressive disease is objectively documented

  After completion of protocol therapy, patients with PR/CR ongoing assessed q3 months until relapse.

  Every 3 months

• Stable disease duration measured from the time of start of therapy until the criteria for progression are met

  After completion of protocol therapy, patients with ongoing SD assess q 3months until progression.

  Every 3 months

• Pharmacokinetics

  cycle 1 and 2

Study Arms (1)

AEG35156 plus docetaxel

EXPERIMENTAL

Drug: AEG35156; Drug: docetaxel

Interventions

AEG35156 DRUG

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.

AEG35156 plus docetaxel

docetaxel DRUG

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.

AEG35156 plus docetaxel

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Locally advanced, metastatic, or recurrent disease that is refractory to standard curative therapy or for which no curative therapy exists * Clinically and/or radiographically documented disease * Docetaxel single-agent therapy must be a reasonable treatment option * No newly diagnosed CNS metastases * Previously treated, intracranial disease that has been stable for ≥ 6 months allowed PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin normal * Creatinine normal * AST and ALT ≤ 1.5 times upper limit of normal * PT or INR normal * PTT normal * No known bleeding disorder * No preexisting peripheral neuropathy ≥ grade 2 * No prior serious allergic reaction to taxanes (e.g., paclitaxel or docetaxel) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious illness or medical condition that would be aggravated by treatment or preclude study requirements, including any of the following: * Serious uncontrolled infection * Significant cardiac dysfunction * Significant neurological disorder PRIOR CONCURRENT THERAPY: * No more than 2 prior chemotherapy regimens for metastatic or recurrent disease * No more than 1 prior adjuvant chemotherapy regimen * No more than 1 prior taxane-containing regimen * At least 4 weeks since prior chemotherapy and recovered * At least 4 weeks since prior external-beam radiotherapy provided \< 30% of marrow-bearing areas are irradiated\* * At least 4 weeks since prior investigational agents or new anticancer therapy * At least 2 weeks since prior hormonal therapy or immunotherapy * At least 2 weeks since prior surgery and recovered * No prior nephrectomy * No concurrent anticoagulant therapy in therapeutic doses * Nontherapeutic dose anticoagulant therapy (e.g., 1 mg warfarin once daily) allowed * No other concurrent experimental drugs or anticancer therapy * No other concurrent cytotoxic therapy or radiotherapy * Small-volume, nonmyelosuppressive palliative radiotherapy allowed NOTE: \*Exceptions are made for prior low-dose non-myelosuppressive radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (3)

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

MeSH Terms

Interventions

AEG 35156; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Gerald Batist, MD

  Jewish General Hospital

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 27, 2006
• Study Start: June 9, 2005
• Primary Completion: September 26, 2006
• Study Completion: June 7, 2010
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)