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

• Sponsor: University of Louisville (Other)
• Overall Status: Completed
• CT.gov ID: NCT00456989
• Collaborator: James Graham Brown Cancer Center (Other)
• Enrollment: 39
• Location: 1
• Arm: 1
• Duration (Months): 79
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Taxotere; Drug: Doxil	Phase 1/Phase 2

Detailed Description

Each cycle of treatment will consist of four weeks. The 2 types of medicines are given intravenously (in a vein). Doxil is given on the first day of each cycle. Taxotere is given once a week for the first 3 weeks of each cycle. This is followed by a week of rest until the next cycle starts. Treatment is given on an outpatient basis and hospitalization is not anticipated.

Prior to entry on this study, "screening" tests are performed to determine eligibility to participate. This will involve a complete history and physical examination, vital signs, pain assessment, blood tests including CBC (complete blood count), serum chemistry, and PSA (prostate specific antigen), x-rays (chest x-ray, possible plain films of bones if there are abnormal findings on bone scan for clarification), computerized tomography (CT) scans of the abdomen and pelvis, bone scans, a MUGA scan or 2-D echocardiogram, and a quality of life questionnaire.

After treatment starts the following tests are done to regularly monitor for beneficial and toxic effect of the treatment:

Every week: blood tests.

Every month: physical examination, weight, vital signs (blood pressure, respiration, temperature and heart rate) and PSA test.

Every 2 months: pain assessment, quality of life questionnaire, x-rays (chest x-ray and possible pain films of bones if positive findings are seen on bone scan), computerized tomography (CT) scans (abdomen and pelvis) and bone scans.

Participants may continue with any procedures that are part of their regular cancer care. It is anticipated that participants will be in the study for a minimum of 2 months and as long as they are benefiting from the treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Study of Docetaxel (Taxotere) in Combination With Doxorubicin HCI Liposome Injection (Doxil) in Advanced Androgen-Independent Prostate Cancer (AIPC)
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Taxotere and Doxil 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; 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.; Drug: Doxil; 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.

Outcome Measures

Primary Outcome Measures

1. Maximum Tolerated Dose and Toxicity Profile [2 years]

Secondary Outcome Measures

1. Response Rate [7 years]

   Data not analyzed, PI left institution

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

• AST(SGOT) and ALT(SGPT) and Alkaline Phosphatase must be within the range allowing for eligibility

• Patients must have adequate renal function as defined by a creatinine < 2.5 mg/dl or a creatinine clearance > 30 mL/min (measured or estimated by the Cockroft formula) for patients with creatinine levels above 2.5 mg/dl

• Patients must have recovered from acute toxicities from chemotherapy or radiotherapy administered prior to entering this study. Alopecia may not be resolved and peripheral neuropathy (grade 1) may be present.

• Patients must have a MUGA scan or 2-d echocardiogram indicating an ejection fraction of > 50% within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring.

• Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.

• Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	James Graham Brown Cancer Center	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• University of Louisville
• James Graham Brown Cancer Center

Investigators

• Principal Investigator: Damian Laber, MD, James Graham Brown Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Louisville
• ClinicalTrials.gov Identifier: NCT00456989
• Other Study ID Numbers: IRB# 575-03
• First Posted: Apr 5, 2007
• Last Update Posted: Oct 30, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by University of Louisville: Androgen Independent; Prostate Cancer; Taxotere; Doxil; AIPC; Advanced Androgen-Independent Prostate Cancer
• Additional relevant MeSH terms: Prostatic Neoplasms; Docetaxel

Study Results

Participant Flow

Arm/Group Title	Taxotere and Doxil
Arm/Group Description	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. Taxotere: 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. Doxil: 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.
Period Title: Overall Study
STARTED	39
COMPLETED	39
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Taxotere and Doxil
Arm/Group Description	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. Taxotere: 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. Doxil: 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.
Overall Participants	39
Age, Customized (Number) [Number]
>=18	39 100%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	39 100%

Outcome Measures

1. Primary Outcome

Title	Maximum Tolerated Dose and Toxicity Profile
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study

Arm/Group Title	Taxotere and Doxil
Arm/Group Description	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. Taxotere: 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. Doxil: 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.
Measure Participants	0

2. Secondary Outcome

Title	Response Rate
Description	Data not analyzed, PI left institution
Time Frame	7 years

Outcome Measure Data

Analysis Population Description

There is no data to report. Data for this trial was not analyzed, the PI left institution.

Arm/Group Title	Taxotere and Doxil
Arm/Group Description	There is no data to report. Data for this trial was not analyzed, the PI left institution. 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. Taxotere: 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. Doxil: 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. There is no data to report. Data for this trial was
Measure Participants	0

Adverse Events

Arm/Group Title	Taxotere and Doxil
Arm/Group Description	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. Taxotere: 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. Doxil: 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.
All Cause Mortality
	Taxotere and Doxil
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Taxotere and Doxil
	Affected / at Risk (%)	# Events
Total	8/39 (20.5%)
Gastrointestinal disorders
Diarrhea	1/39 (2.6%)	1
General disorders
Fatique	2/39 (5.1%)	2
Fever	1/39 (2.6%)	1
Bleeding	2/39 (5.1%)	2
Mouth pain	1/39 (2.6%)	1
Infections and infestations
Bacterial meningitis	1/39 (2.6%)	1
Other (Not Including Serious) Adverse Events
	Taxotere and Doxil
	Affected / at Risk (%)	# Events
Total	0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.