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

• Status: Completed
• Trial end date: 2012-01-06
• Target enrollment: 0
• Participant gender: All

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 locally advanced, metastatic, or recurrent solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Docetaxel

Criteria

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 radiologically documented disease

• Treatment with single-agent docetaxel is a reasonable treatment option

• No newly diagnosed CNS metastases

• Previously treated and stable (≥ 6 months) intracranial disease allowed

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 12 weeks

• Absolute granulocyte count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• PT or INR and PTT normal

• Creatinine normal

• Bilirubin normal

• AST and ALT ≤ 1.5 times upper limit of normal (ULN)

• Gamma-glutamyl transferase ≤ 3 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No underlying serious illness or medical condition that might be aggravated by treatment or might interfere with study treatment, including, but not limited to, the following:

• Serious uncontrolled infection

• Significant cardiac dysfunction

• Significant neurological disorder that would impair the ability to obtain informed consent

• No known bleeding disorders

• No prior serious allergic reaction to taxane (paclitaxel or docetaxel)

• No pre-existing peripheral neuropathy ≥ grade 2

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior chemotherapy and recovered

• At least 2 weeks since prior hormonal therapy or immunotherapy

• At least 4 weeks since prior external-beam radiotherapy to < 30% of marrow-bearing areas

• Low-dose, nonmyelosuppressive radiotherapy allowed

• At least 2 weeks since prior surgery and recovered

• More than 4 weeks since prior investigational agents or new anticancer therapy

• No prior nephrectomy

• No other concurrent chemotherapy

• No concurrent radiotherapy

• Small-volume, non-myelosuppressive palliative radiotherapy allowed

• No other concurrent experimental drugs or anticancer therapy

• No concurrent therapeutic dose anticoagulant therapy

• Non-therapeutic dose anticoagulant therapy (i.e., 1 mg daily oral warfarin) allowed