Trial · Interventional

CompletedPhase 2Results postedRegistry data

Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

NCTNCT00587431Other id03-076

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 102 participants (actual)
Sponsor: Memorial Sloan Kettering Cancer Center · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jul 2003
Primary completion: Feb 2008
Completion: Feb 2008
First posted: 7 Jan 2008 (estimated)
Last update posted: 7 Nov 2023
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2003200420052006200720082009

Ph 2
Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer
NCT00587431
Jul 2003 to Feb 2008

Registry summary

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

We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.

Interventions

GnRh (Leuprolide)Drug
Testosterone GelDrug
DocetaxelDrug

Arms2

Experimental
1
Active comparator
2

Primary outcomes1

Outcomes the sponsor listed as primary.

PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy
Time frame · Conclusion of the study (at 6 months then at 18 months post-treatment)

Secondary outcomes(1)

The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.
Time frame · at Cycle 1 and 2
Registry description
Docetaxel Pharmacokinetic parameters for cycles 1 and 2.

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· Conclusion of the study (at 6 months then at 18 months post-treatment)

PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy

Group	Value (participants)
Lupron + Docetaxel (75mg/m2) +Testosterone (RISING PSA)	9
Lupron + Docetaxel (75mg/m2) + Testosterone for (Metastatic)	14
Lupron +Docetaxel (70 mg/m2) +Testosterone (RISING PSA)	13
Lupron + Docetaxel (70 mg/m2) + Testosterone (Metastatic)	12

Secondary and other outcome results(1)

Secondary outcomeMean· at Cycle 1 and 2

The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.

Group	Value (L/hr)	Spread
All Participants	23.9	12.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Lupron and Docetaxel (75mg/m2) and Testosterone for 7 DaysGnRh (Leuprolide): Leuprolide LUPRON Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days	–	36 / 63	63 / 63
Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 DaysGnRh (Leuprolide): Leuprolide LUPRON Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days	–	8 / 39	39 / 39

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC. * Patient must have a serum testosterone \> 180 ng/dl. * Karnofsky performance status (KPS)\>\_70%. * Patients must have adequate organ function as defined by the following * laboratory criteria: * WBC \>\_ 3500/mm3 * ANC \>\_1500/mm3 * Platelet count \>100,000/mm3 * Hemoglobin \>8.0g/dL * Creatinine \<1.6mg/dl * Total Bilirubin WNL (unless due to Gilbert's disease and other LFTs are WNL) * SGOT and SGPT If alkaline phosphatase is \_\< 2.5 x ULN, any elevations in * AST/ALT; OR if AST/ALT is \_\<1.5 x ULN, any elevation in alkaline phos * Prior hormonal therapy is allowed as: 1. Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy, provided that the total duration of therapy does not exceed 6 months (Proscar is not considered a hormone therapy). 2. One cycle of intermittent therapy up to a maximum exposure of 6 months (Proscar is not considered a hormone therapy). * Patients must be at least 18 years of age. * Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment Exclusion Criteria: * Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease. * Uncontrolled serious active infection. * Anticipated survival of less than 3 months. * Active CNS or epiduraltumor * Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests * Peripheral neuropathy \>\_ grade 3. * Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80. * Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment. * Prior chemotherapy * Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.

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