Study of Taxotere and Doxil to Treat Advanced Androgen-Independent Prostate Cancer

NCT00456989 | Completed Phase 1 Results

• 1 other identifier: IRB# 575-03
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical research study is being done because there is no effective treatment for advanced androgen-independent prostate cancer. This study will determine if the combination of medications (Taxotere and Doxil) are effective in this kind of cancer.

Conditions

Prostate Cancer

Keywords

Androgen Independent; Prostate Cancer; Taxotere; Doxil; AIPC; Advanced Androgen-Independent Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose and Toxicity Profile

  2 years

Secondary Outcomes (1)

• Response Rate

  7 years

Study Arms (1)

Taxotere and Doxil

EXPERIMENTAL

Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.

Drug: Taxotere; Drug: Doxil

Interventions

Taxotere DRUG

Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.

Taxotere and Doxil

Doxil DRUG

Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.

Taxotere and Doxil

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate.
• Androgen-independent disease progression, as shown by:
• A castrate testosterone level of \< 40 ng/dl (this measurement is required only for patients treated with medical testicular suppression). If testicular suppression is achieved medically, treatment to maintain castrate levels of testosterone must be applied continuously.
• A PSA level of at least 4 ng/ml, and rising (with an absolute change of at least 1 ng/ml) on two consecutive measurements at least 2 weeks apart prior to study entry.
• Patients must be off anti-androgens such as flutamide (Eulexin) or nilutamide (Nilandron) for at least four weeks, and six weeks for bicalutamide (Casodex), without evidence of response; or have evidence of progression since anti-androgen withdrawal.
• None or one previous cytotoxic therapy is allowed. (For this study, a combination of agents given at the same period of time is considered one chemotherapy treatment)
• Age \> 18 years of age.
• Life expectancy of greater than 12 weeks.
• ECOG performance status 0, 1 or 2 (Karnofsky \>50%; see Appendix B).
• Patients must have adequate bone marrow function as defined below:
• absolute neutrophil count \> 1,500/ul
• platelets \> 100,000/ul
• hemoglobin \> 8 g/dl
• Patients must have adequate liver function as defined below:
• total bilirubin normal, albumin \> 3.0 g/dl, and no ascites

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
• Patients who have had two or more prior chemotherapy treatment(s) (For this study, a combination of agents given at the same period of time is considered one chemotherapy treatment).
• Patients receiving any other investigational agent(s).
• Patients with symptomatic brain metastases or actively receiving any therapy for brain metastasis (because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events).
• Active second malignancy in the last 5 years except for non-melanoma skin cancer or carcinoma-in-situ.
• History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure.
• History of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL, the components of Doxil, docetaxel or other drugs formulated with polysorbate 80.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Laber DA, Eatrides J, Jaglal MV, Haider M, Visweshwar N, Patel A. A phase I/II study of docetaxel in combination with pegylated liposomal doxorubicin in metastatic castration-resistant prostate cancer. Med Oncol. 2020 Sep 26;37(10):95. doi: 10.1007/s12032-020-01420-7.

  PMID: 32979106 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; liposomal doxorubicin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: University of Louisville, James Graham Brown Cancer Center Clinical Trials
• Organization: University of Louisville, James Graham Brown Cancer Center

ctobcc@louisville.edu

502-562-3429

Study Officials

• Damian Laber, MD

  James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 5, 2007
• Study Start: January 1, 2004
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 30, 2019
• Results First Posted: October 9, 2014

Record last verified: 2019-10

Locations

US (1)