Clinical trial · Interventional
GTI-2040, Docetaxel, and Prednisone in Treating Patients With Prostate Cancer
A Phase II Study of GTI-2040 in Combination With Docetaxel and Prednisone in Hormone-Refractory Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| GTI-2040 | Biological | — | UNRESOLVED |
| prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- PSA response rate
Secondary outcomes (3)
- measure
- Median survival
- measure
- 1-year survival
- measure
- Response rate and duration
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 therapiesReferences
Publications (1)
- RESULTSridhar 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