NCT00016913|CompletedPhase 2Results

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

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

CALGB-99811U10CA031946CDR0000068632

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedMay 2001

CompletionMay 2008

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline

Completed

Started May 2001

Longer than P75 for phase_2 prostate-cancer

Geographic Reach

1 country

23 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 years study duration

Study Start

First participant enrolled

May 1, 2001

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed

1.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed

7.8 years until next milestone

Results Posted

Study results publicly available

January 29, 2016

Completed

Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

6.2 years

First QC Date

June 6, 2001

Results QC Date

July 31, 2015

Last Update Submit

July 1, 2016

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage III prostate cancer

Outcome Measures

Primary Outcomes (1)

Toxicity
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.
90 days and 1 year post treatment

Secondary Outcomes (2)

Time to Prostate-specific Antigen Failure
PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years).
Progression-free Survival (PFS)
registration to progression, up to 5.5 years from registration

Study Arms (1)

Neo-Adj ChemoTx + ablation prior to RT

EXPERIMENTAL

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.

Drug: carboplatinDrug: estramustineDrug: paclitaxelRadiation: radiation therapyDrug: leuprolide or goserelin acetate