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Alkylating agent

Olaparib + Chemotherapy for Prostate Cancer

Phase 2
Waitlist Available
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must meet at least one of the following AVPC criteria: i. Histologically proven small cell (neuroendocrine) prostate carcinoma ii. Exclusive visceral metastases. iii. Predominantly lytic bone metastases identified by plain x-ray or CT scan. iv. Bulky (>/= 5cm in longest dimension) lymphadenopathy or high-grade tumor mass in prostate/pelvis. v. Low PSA (</= 10ng/mL) at initial presentation (prior to androgen ablation or at symptomatic progression in the castrate-setting) plus high volume (>/= 20) bone metastases. vi. Elevated serum lactate dehydrogenase (>/=2 x upper limit of normal) or elevated serum carcinoembryonic antigen (>/= 2 x upper limit of normal ) in the absence of other etiologies. vii. Short interval (</= 180 days) to castrate-resistant progression following initiation of hormonal therapy. viii. Known loss or mutation (by CLIIA certified molecular testing, IHC and/or DNA sequencing) in at least 2 of the following: Tp53, RB1 and PTEN
Patients must have normal organ and bone marrow function measured within 7 days prior to administration of study treatment as defined below: i. Hemoglobin >/= 10.0 g/dL dL (unless due to bone marrow infiltration by tumor, in which case hemoglobin >/=8gdL is allowed). Patient may have blood transfusions prior to study enrollment. ii. Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L (unless due to bone marrow infiltration by tumor, in which case ANC >1,000/mm3 is allowed) iii. White blood cells (WBC) >3x10^9/L (unless due to bone marrow infiltration by tumor, in which case WBC >2x109/L is allowed) iv. No features suggestive of myelodysplastic syndrome/acute myeloid leukemia on peripheral blood smear v. Platelet count >/= 100 x 10^9/L (unless due to bone marrow infiltration by tumor, in which case platelet >/=50,000/ mm3 is allowed) vi. Total bilirubin </=1.5 x institutional upper limit of normal (ULN) (except for patients with known Gilbert's disease) vii. aspartate aminotransferase (serum glutamine oxaloacetic transminase) and alanine aminotransferase (serum glutamic pyruvic transaminase) </= 2.5 x institutional upper limit of normal (unless liver metastases are present in which case it must be </= 5x ULN) viii. Calculated creatinine clearance (Cockcroft-Gault Equation) >/= 40 mL/min
Must not have
Any prior treatment for castration-resistant prostate cancer (CRPC) with carboplatin, cisplatin, cabazitaxel or olaparib
Patients with a known hypersensitivity to the olaparib, carboplatin or cabazitaxel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year from time of randomization
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 30 Other Conditions

Summary

This trial is studying olaparib to see how well it works in combination with cabazitaxel, carboplatin, and prednisone in treating patients with aggressive variant prostate cancer.

Who is the study for?
This trial is for men over 18 with aggressive variant prostate cancer (AVPC) that's resistant to castration and has spread. They must have normal organ function, be able to swallow pills, consent to genetic research, and use birth control if needed. Excluded are those with certain medical conditions or who've had specific treatments for CRPC.
What is being tested?
The study tests if olaparib can control AVPC after treatment with cabazitaxel, carboplatin, and prednisone. It's an investigational study of these drugs' combination; up to 96 participants at MD Anderson will receive this regimen following informed consent.
What are the potential side effects?
Possible side effects include allergic reactions to the medications used, gastrointestinal issues due to oral medication intake, potential liver problems from drug interactions or pre-existing conditions, blood disorders like myelodysplastic syndrome/acute myeloid leukemia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man aged 18 or older.
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My prostate cancer diagnosis was confirmed through lab tests.
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I can perform daily activities with minimal assistance.
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My cancer is getting worse, shown by tests or new symptoms.
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My prostate cancer is resistant to hormone therapy and is worsening, but my PSA levels are not rising.
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I can swallow pills whole.
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I am undergoing treatment to lower my testosterone levels below 50 ng/dL.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated for prostate cancer with specific drugs.
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I am allergic to olaparib, carboplatin, or cabazitaxel.
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I cannot swallow pills or have stomach issues affecting medication absorption.
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I have recovered from side effects of cancer treatment, except for specific prostate cancer therapies.
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I am not currently using strong or moderate drugs that affect liver enzymes.
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I am diagnosed or suspected to have a blood disorder or leukemia.
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I have active hepatitis or chronic liver disease.
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I have had lung inflammation or widespread lung disease not caused by cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year from time of randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year from time of randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS) of men with AVPC treated with 6 cycles of cabazitaxel + carboplatin followed by olaparib maintenance versus observation

Side effects data

From 2017 Phase 2 trial • 85 Patients • NCT01757171
70%
Fatigue
48%
Anemia
44%
Nausea
35%
Neutropenia
33%
Abdominal pain
33%
Diarrhea
33%
Vomiting
30%
Constipation
26%
Edema limbs
26%
Peripheral sensory neuropathy
26%
decreased WBC count
22%
Abdominal distension
22%
Dyspnea
19%
Anxiety
19%
Insomnia
15%
Hypotension
15%
Cough
15%
Dizziness
13%
Decreased white blood cell count
11%
Urinary frequency
11%
Dyspepsia
11%
decreseaed neutrophill count
11%
Weight loss
11%
Dysuria
9%
Death
9%
Thromboembolic event
7%
Dysphagia
7%
Flatulence
7%
Increased Abdominal Girth
7%
Paresthesia
7%
Depression
7%
Hematuria
7%
Dry skin
7%
Hypertension
7%
Alopecia
7%
generalized weakness
7%
Gastric hemorrhage
7%
Lightheadedness
7%
Weakness
7%
Fever
4%
renal failure
4%
Positive blood culture
4%
Early Satiety
4%
decreased urine output
4%
balance difficulty
4%
Pleural Effusion
4%
Abdominal Pain
4%
Acute Kidney Failure
4%
Mycoplasma pneumoniae
4%
Acinetobacter baumanii bacteremia
4%
Ascites
4%
Bacteremia
4%
Increased generalized weakness
4%
Dehydration
4%
Nasal congestion
4%
Shortness of Breath
4%
Nephrolithiasis (Kidney Stone)
4%
Difficulty Urinating
4%
Allergic reaction
4%
Decreased Appetite
4%
Mouth ulcer
4%
Loose Stools
4%
Right Upper Quadrant Pain
4%
hyperlipidemia
4%
Gastric Hemorrhage
4%
Hypocalcemia
4%
Myelosuppression
4%
Cardiac arrest
4%
Gastrointestinal pain
4%
Mucositis oral
4%
Stomach pain
4%
Anasarca
4%
Anal fissure
4%
burping
4%
Skin Changes
4%
Hypokalemia
4%
Dysguesia
4%
Poor Appetite
4%
Hypoalbuminemia
4%
Poor Oral Intake
4%
Headache
4%
hypersensitivity
4%
Agitation
4%
Cystitis noninfective
4%
Nocturia
4%
UROSEPSIS
4%
Prostatitis
4%
Bengin enlargement of Prostate
4%
Hydrouretroneprosis
4%
benign prostatic hypertrophy
4%
urosepsis
4%
Hydronephrosis
4%
Renal Failure
4%
Urinary tract obstruction
4%
Hiccups
4%
Allergic rhinitis
4%
Epistaxis
4%
VATS pleurodesis
4%
Sore throat
4%
Hypohidrosis
4%
Nail discoloration
4%
slow skin turgor
4%
Rash
4%
flushing
4%
Nodular findings
4%
easy bruisability
4%
Hyperhidrosis
4%
Rectal Obstruction
4%
mouth sore
4%
Sepsis
4%
Bacteruria
4%
Bone Mets
4%
Dysgeusia
4%
Hypothyroidism
4%
Chills
4%
Dysmenorrhea
4%
Concentration impairment
4%
Bloating
4%
Edema- Scrotal
4%
Rash on Neck
4%
Weight Change
4%
Body aches
4%
Proteinuria
4%
Hyponatremia
4%
Clostridium difficle
4%
intermittent low appetite
4%
neuropathy to fingers
4%
hiatal hernia
4%
Elevated CEA
4%
cold intolerance
4%
Urinary Tract Infection
4%
Urinary Tract Obstruction
4%
increased tears
4%
early satiety
4%
Localized edema
4%
Malaise
4%
Non-cardiac chest pain
4%
Rigors
4%
Big white light and dizziness
4%
decreased absolute lymphocyte count
4%
decreased platelets
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Prior Taxane Therapy)
Arm A (Taxane naïve)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Olaparib MaintenanceExperimental Treatment1 Intervention
Participants randomized to receive Olaparib by mouth twice daily on Day 1 of cycle 7.
Group II: Cabazitaxel + CarboplatinExperimental Treatment3 Interventions
Cabazitaxel, Cabazitaxel and Carboplatin intravenously on day 1 of cycles 1-6. Prednisone by mouth twice daily on days 1-21 of cycles 1-6.
Group III: Observation OnlyActive Control1 Intervention
Participants randomized to observation only beginning cycle 7.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Carboplatin
FDA approved
Cabazitaxel
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,472 Total Patients Enrolled
88 Trials studying Prostate Cancer
28,628 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,427 Previous Clinical Trials
289,164,492 Total Patients Enrolled
57 Trials studying Prostate Cancer
25,332 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,723 Total Patients Enrolled
28 Trials studying Prostate Cancer
17,494 Patients Enrolled for Prostate Cancer
Ana M. Aparicio, MDStudy ChairUT MD Anderson Cancer Center
3 Previous Clinical Trials
153 Total Patients Enrolled
2 Trials studying Prostate Cancer
151 Patients Enrolled for Prostate Cancer

Media Library

Cabazitaxel (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT03263650 — Phase 2
Prostate Cancer Research Study Groups: Cabazitaxel + Carboplatin, Observation Only, Olaparib Maintenance
Prostate Cancer Clinical Trial 2023: Cabazitaxel Highlights & Side Effects. Trial Name: NCT03263650 — Phase 2
Cabazitaxel (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03263650 — Phase 2
~8 spots leftby Jun 2025
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