GTI-2040, Docetaxel, and Prednisone in Treating Patients With Prostate Cancer

NCT00087165 | Completed Phase 2

• 3 other identifiers: PMH-PHL-024CDR0000372951NCI-6102
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: GTI-2040 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. GTI-2040 may help docetaxel kill more tumor cells by making them more sensitive to the drug. PURPOSE: This phase II trial is studying how well giving GTI-2040 together with docetaxel and prednisone works in treating patients with prostate cancer that has not responded to hormone therapy.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer

Outcome Measures

Primary Outcomes (1)

• PSA response rate

Secondary Outcomes (3)

• Median survival

• 1-year survival

• Response rate and duration

Interventions

GTI-2040 BIOLOGICAL

docetaxel DRUG

prednisone DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Metastatic carcinoma of presumptive prostate origin * Bony metastases AND a serum prostate-specific antigen (PSA) level \> 20 ng/mL * Disease progression after prior hormonal therapy as defined by rising PSA levels * At least 2 consecutive rises in PSA over a reference value, with measurements taken at least 7 days apart * Prior hormonal therapy must include either medical (luteinizing hormone-releasing hormone \[LHRH\] agonist) OR surgical (orchiectomy) castration * Patients who received prior LHRH agonist must continue or re-start such therapy * Castrate levels of testosterone \< 50 ng/dL * PSA ≥ 20 ng/mL * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * WBC ≥ 3,000/mm\^3 Hepatic * AST and ALT ≤ 1.5 times upper limit of normal (ULN) * Bilirubin normal * PTT ≤ 1.25 times upper limit of control * INR ≤ 1.3 Renal * Creatinine ≤ 1.5 times ULN OR * Creatinine clearance ≥ 50 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Fertile patients must use effective contraception * No symptomatic peripheral neuropathy ≥ grade 2 * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to GTI-2040 or other study agents * No concurrent uncontrolled illness * No active or ongoing infection * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic filgrastim (G-CSF) or epoetin alfa Chemotherapy * No prior chemotherapy except monotherapy with oral estramustine * At least 4 weeks since prior estramustine and recovered Endocrine therapy * See Disease Characteristics * At least 6 weeks since prior bicalutamide\* * At least 4 weeks since prior flutamide, nilutamide, or cyproterone\* * Concurrent steroids allowed NOTE: \*Patients must have evidence of disease progression despite cessation of antiandrogen therapy Radiotherapy * At least 4 weeks since prior radiotherapy * No prior radiotherapy to \> 25% of bone marrow * No prior isotope therapy Surgery * See Disease Characteristics Other * No concurrent prophylactic antibiotics * No concurrent anticoagulants * Concurrent low-dose warfarin for prophylaxis of central line thrombosis allowed * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents or therapies

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Sridhar SS, Canil CM, Chi KN, Hotte SJ, Ernst S, Wang L, Chen EX, Juhasz A, Yen Y, Murray P, Zwiebel JA, Moore MJ. A phase II study of the antisense oligonucleotide GTI-2040 plus docetaxel and prednisone as first-line treatment in castration-resistant prostate cancer. Cancer Chemother Pharmacol. 2011 Apr;67(4):927-33. doi: 10.1007/s00280-010-1389-7. Epub 2010 Jul 3.

  PMID: 20602233 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

GTI2040; Docetaxel; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Malcolm J. Moore, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: January 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: December 1, 2006
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CA (5)