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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

NCTNCT00016913 (opens ClinicalTrials.gov in a new tab)Other idCALGB-99811Other idU10CA031946Other idCALGB-99811Other idCDR0000068632
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
34 participants (actual)
Sponsor
Alliance for Clinical Trials in Oncology · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
May 2001
Primary completion
Jul 2007
Completion
May 2008
First posted
27 Jan 2003 (estimated)
Last update posted
6 Jul 2016 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2002200420062008
  1. Ph 2

    Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

    NCT00016913

    May 2001 to May 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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.

Interventions

  • carboplatinDrug
  • estramustineDrug
  • paclitaxelDrug
  • radiation therapyRadiation
  • leuprolide or goserelin acetateDrug

Arms1

  • Experimental

    Neo-Adj ChemoTx + ablation prior to RT

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Toxicity

    Time frame · 90 days and 1 year post treatment

    Registry 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.

Secondary outcomes(2)

  1. Time to Prostate-specific Antigen Failure

    Time frame · 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).

    Registry description

    PSA progression was defined in 2 ways. The CALGB PSA progression was defined as 2 consecutive rises in PSA with a rise of at least 0.2 ng/mL and above 1.0 ng/mL after radiation therapy; the date of PSA failure is taken as the midpoint between the last PSA before the rise and the first of the 2 PSAs that documented the rise. In addition, PSA progression was used according to the American Society for Therapeutic Radiology and Oncology 1996 (ASTRO) criteria and defined as 3 consecutive rises in PSA after radiation therapy. The date of PSA failure was taken as the midpoint between the time of the lowest PSA measure after irradiation and the first of the 3 consecutive rises.

  2. Progression-free Survival (PFS)

    Time frame · registration to progression, up to 5.5 years from registration

    Registry description

    PFS was defined as the time between treatment initiation and the date of disease progression (PSA, bone, tumor) or death, whichever occurred first. PSA progression is defined as 2 consecutive rising PSAs (a rise of at least 0.2 ng/mL) above 1.0 ng/mL.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 90 days and 1 year post treatment

Toxicity

GroupValue (Events)
Neo-Adj ChemoTx + Ablation Prior to RT2
Secondary and other outcome results(2)
Secondary outcomeMedian· 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).

Time to Prostate-specific Antigen Failure

GroupValue (months)
Neo-Adj ChemoTx + Ablation Prior to RT17.1
Secondary outcomeMedian· registration to progression, up to 5.5 years from registration

Progression-free Survival (PFS)

GroupValue (months)
Neo-Adj ChemoTx + Ablation Prior to RT12.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Neo-Adj ChemoTx + Ablation Prior to RTTreatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer.–0 / 2929 / 29

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2008

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.

Kelly et al. 2008Cancercited by 10

PMID 18989865DOI 10.1002/cncr.23910PUB-18989865

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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