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Status:

COMPLETED

AEG35156 and Docetaxel in Treating Patients With Solid Tumors

Lead Sponsor:

NCIC Clinical Trials Group

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18-120 years

Phase:

PHASE1

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 doc...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose and define the recommended phase II dose of AEG35156 in combination with docetaxel in patients with solid tumors. Secondary * Determine t...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 9 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 7 2010

    Estimated Enrollment :

    10 Patients enrolled

    Trial Details

    Trial ID

    NCT00357747

    Start Date

    June 9 2005

    End Date

    June 7 2010

    Last Update

    August 4 2023

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada, V5Z 4E6

    2

    Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, Canada, M5G 2M9

    3

    McGill University - Dept. Oncology

    Montreal, Quebec, Canada, H2W 1S6