Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

NCT00049257 | Completed Phase 2 Results DMC

• 4 other identifiers: CDR0000258050UCLA-0202092BMS-UCLA-020209201NCI-G02-2121
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel with carboplatin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (2)

• Prostate-specific Antigen (PSA) Response Rate

  PSA response is defined as a decline from the baseline value of \>=50% confirmed by a second PSA value 4 or more weeks later.

  Evaluated every 28 days during Treatment Period. Number of completed cycles among 58 treated patients range from 1 to 24 cycles with a median of 4.5 cycles. one cycle = 28 days.

• Time to PSA Progression

  In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline value and an increase in the absolute value PSA level by \>=5ng/ml, confirmed by a second value at \>=4 week intervals. In patients whose PSA has decreased but has not reached response criteria, progressive disease is defined as an increase in PSA by 25% over the nadir, provided that the increase is \>=5ng/ml and is confirmed by a second value at \>=4 week intervals.

  Evaluated every 28 days during Treatment Period

Secondary Outcomes (2)

• Objective Response Rate

  Evaluated every 12 weeks during Treatment Period

• Overall Survival Rate

  Assessed every two months after completion of study treatment for 4 years

Study Arms (1)

Treatment

EXPERIMENTAL

Please see intervention descriptions

Drug: carboplatin; Drug: paclitaxel

Interventions

carboplatin DRUG

Administered Day 1 of each cycle. AUC=6.

Also known as: Paraplatin

Treatment

paclitaxel DRUG

administered Days 1, 8, and 15 of each cycle. 100mg/m2

Also known as: Taxol

Treatment

Eligibility Criteria

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

You may qualify if:

• Patients must be informed of investigational nature of the study and written informed consent must be obtained prior to study entry
• Patients \>18 years of age
• Patients with a histologic diagnosis of adenocarcinoma of the prostate
• Patients must have metastatic disease with progression despite androgen ablation. Patients who have not undergone orchiectomy must continue LHRH analogues. For patients receiving LHRH analogues their testosterone level must be \< 50ng/dL
• Patients with bidimensionally measurable disease or bone metastases that is not progressive but who have a rising PSA are eligible
• Patients with an ECOG performance status \<2
• Patients must have discontinued flutamide or nilutamide at least 4 weeks prior to the first day of treatment with evidence of progressive disease. Patients must have discontinued bicalutamide at least 6 weeks prior to registration with evidence of progressive disease
• Patients with adequate hematological, renal, and hepatic function as defined by the following required laboratory values:
• While blood cell count: \> 3,000/mm3
• Absolute granulocyte count: \> 1,500/mm3
• Platelets: \> 100,000/mm3
• Hemoglobin: \> 8.5 g/dL
• Total bilirubin: \< 1.5 mg/dL
• Serum creatinine: \< 2.5 mg/dL
• AST or ALT: \< 2.5 x institutional upper limit of normal

You may not qualify if:

• Patients with biochemical only progression
• Patients who have received any prior chemotherapy for cancer of the prostate
• Patients who received antiandrogen therapy within 4 weeks prior to the first day of treatment after cessation of flutamide or nilutamide, and or within 6 weeks prior to registration after cessation of bicalutamide
• Patients receiving concomitant chemotherapy, biologic therapy, or radiation therapy
• Patients who have received Strontium 89 or other radioisotope therapies
• Patients with decreasing PSA levels following antiandrogen withdrawal
• Patients with \> grade 1 peripheral sensory or motor neuropathy
• Patients with known carcinomatous meningitis or brain metastases are excluded
• Patients with past or current histories of neoplasm other than entry diagnosis except for in-situ carcinoma of any site, non-melanoma skin cancer, or other malignancy treated by surgery or radiation with a disease-free survival longer than 5 years
• Patients who have undergone major surgery \< 3 weeks prior to registration, except for biopsy or placement of a venous access device. Patients must have fully recovered from all effects of any prior surgery
• Patients with histories of serious cardiac disease not adequately controlled: documented myocardial infarction within the last 6 months preceding registration, congestive heart failure, unstable angina, valvular disease with documented ventricular compromise, uncontrolled hypertension, arrhythmia uncontrolled by medication, clinically significant pericardial effusion
• Patients with active serious infections or other serious underlying medical conditions that would otherwise impair their ability to receive protocol treatments
• Patients with dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent
• Patients receiving other investigational therapy
• Use of any investigational agent within 30 days of first day of treatment and use of Ketoconazole, hydrocortisone, glucocorticoids, or megace within 30 days of first day of treatment or other concomitant medications

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Carboplatin; Paclitaxel

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)

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

Limitations and Caveats

The major weakness of the study is, it is a single-arm non-comparative study. With the small sample size of 58 participants who received treatment, the study does not have the statistical power to make categorical assessments or statements.

Results Point of Contact

• Title: Dr. Fairooz Kabbinavar, Chief Medical Officer
• Organization: Translational Oncology Research International

FKabbina@mednet.ucla.edu

310 824 1934

Study Officials

• Fairooz F. Kabbinavar, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2002
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: September 1, 2020
• Results First Posted: March 15, 2012

Record last verified: 2012-08

Locations

US (1)