CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
carboplatin +4 moredrug
Likely dose
Paclitaxel 80 mg/m² IV weekly; carboplatin AUC=6 every 4 weeks; estramustine 2 tablets three times daily 5 of 7 days per week; leuprolide or goserelin 7.5 mg IM every 4 weeks × 6 months; followed by radiation therapy 77.4 Gy in 1.8 Gy fractionsAI-extracted
Key inclusion· 5
  • ✓Histologically confirmed prostate adenocarcinoma with poor prognosis: either Tx N0 with PSA >20 ng/mL and Gleason ≥7, or T3b-4 N0 disease
  • ✓No pelvic lymph node involvement requiring pelvic radiotherapy
  • ✓No metastatic disease on bone scan, CT, or MRI
  • ✓Age ≥18 years
Key exclusion· 7
  • ✕Prior chemotherapy for prostate cancer
  • ✕Prior immunotherapy for prostate cancer
  • ✕More than 6 weeks of prior androgen deprivation therapy
  • ✕Prior radiotherapy for prostate cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00016913
NCT00016913Phase 2Completed
CompareCT.gov

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

Alliance for Clinical Trials in Oncology·interventional·Posted Jan 27, 2003·Updated Jul 6, 2016

In Brief

A Phase 2 clinical trial evaluating carboplatin, estramustine, and 3 other interventions for Prostate Cancer. Completed, enrolled 34 participants across 23 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMay 1, 2001
Primary CompletionJul 1, 2007
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 23.4 years ago

Interventions

carboplatindrug

AUC=6 week one of each 4 week cycle

estramustinedrug

2 tablets tid PO 5 of 7 days per week each 4 week cycle

paclitaxeldrug

80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle

radiation therapyradiation

77.4 Gy in 1.8 Gy fractions

leuprolide or goserelin acetatedrug

7.5 mg IM injection once every 4 weeks for 6 months