Clinical trial · Interventional
Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
Phase II Study Of Neo-Adjuvant Paclitaxel, Estramustine And Carboplatin (TEC) Plus Androgen Ablation Prior To Radiation Therapy In Patients With Poor Prognosis Localized Prostate Cancer
NCT00016913CI-TRIAL-00022912completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin or leuprolide may stop the adrenal glands from producing androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, hormone therapy, and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying giving chemotherapy together with hormone therapy and radiation therapy in treating patients with locally advanced prostate cancer.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| estramustine | Drug | Estramustine | ALIAS |
| leuprolide or goserelin acetate | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neo-Adj ChemoTx + ablation prior to RT
- description
- Patients with localized high-risk prostate cancer were treated with 4 cycles (16 weeks) of continuous weekly paclitaxel at 80 mg/m\^2 intravenously with estramustine at 280 mg orally 3 times a day for 5 days a week and carboplatin (area under the curve of 6) on Day 1 of every cycle followed by 3-dimensional conformal or intensity-modulated radiotherapy (total dose of 77.4 gray \[Gy\] in 1.8-Gy fractions). All patients received androgen deprivation therapy with either goserelin acetate at 3.6 mg subcutaneously or leuprolide acetate at 7.5 mg intramuscularly monthly for 6 months starting at Day 1 of therapy.
- interventionNames
- Drug: carboplatin
- Drug: estramustine
- Drug: paclitaxel
- Radiation: radiation therapy
- Drug: leuprolide or goserelin acetate
Primary outcomes (1)
- measure
- Toxicity
- timeFrame
- 90 days and 1 year post treatment
- description
- Patients were evaluated for acute toxicities defined as grade 3 or greater cardiovascular (including venous thrombosis), gastrointestinal, or genitourinary toxicity occurring during the period starting from treatment initiation until 90 days or less after the completion of radiotherapy. The same toxicity measures were monitored at \>90 days after the completion of radiotherapy.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate with one of the following prognostic factors: * Tx N0, baseline prostate specific antigen (PSA) greater than 20 ng/mL, and Gleason score at least 7 * T3b-4 N0, any baseline PSA, and any Gleason score * No pelvic lymph node disease requiring pelvic radiotherapy * No metastatic disease by bone scan, CT scan, or MRI PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 1.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No significant cardiovascular disease * No New York Heart Association class III or IV congestive heart failure * No active angina pectoris * No myocardial infarction within the past 6 months * No history of hemorrhagic or thrombotic cerebral vascular accident * No deep vein thrombosis within the past 6 months Pulmonary: * No pulmonary embolism within the past 6 months Other: * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy for prostate cancer * No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy: * No prior chemotherapy for prostate cancer * No other concurrent anticancer chemotherapy Endocrine therapy: * No more than 6 weeks of prior androgen deprivation therapy * No other concurrent anticancer hormonal therapy except steroids for adrenal failure and/or hormones for nondisease-related conditions (e.g., insulin for diabetes) Radiotherapy: * See Disease Characteristics * No prior radiotherapy for prostate cancer * No other concurrent anticancer radiotherapy Surgery: * At least 4 weeks since prior major surgery Other: * No prior alternative therapy (e.g., PC-SPES) for prostate cancer * No concurrent alternative medicine (e.g., PC-SPES or saw palmetto) or large quantities of vitamins * No other concurrent anticancer therapy
References
Publications (1)
- RESULTKelly WK, Halabi S, Elfiky A, Ou SS, Bogart J, Zelefsky M, Small E; Cancer Leukemia Group B. Multicenter phase 2 study of neoadjuvant paclitaxel, estramustine phosphate, and carboplatin plus androgen deprivation before radiation therapy in patients with unfavorable-risk localized prostate cancer: results of Cancer and Leukemia Group B 99811. Cancer. 2008 Dec 1;113(11):3137-45. doi: 10.1002/cncr.23910. PMID 18989865