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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I am undergoing treatment to lower my testosterone levels below 50 ng/dL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to one year from time of randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year from time of randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS) of men with AVPC treated with 6 cycles of cabazitaxel + carboplatin followed by olaparib maintenance versus observation
Secondary outcome measures
Association between DDR pathway gene expression changes following carboplatin + cabazitaxel chemotherapy and clinical outcome (PFS>6 months)
Collection and archiving of serum, plasma, and urine samples in study patients for later hypothesis generating associations
Genomic alterations in DNA damage repair (DDR) pathway genes induced and/or selected by carboplatin and cabazitaxel chemotherapy [biopsy #2 vs biopsy #1]: Association with clinical outcome (PFS>6 months)
+3 moreSide effects data
From 2017 Phase 2 trial • 85 Patients • NCT0175717189%
Fatigue
47%
Abdominal pain
47%
Anemia
45%
Nausea
30%
Constipation
30%
Peripheral sensory neuropathy
26%
Diarrhea
26%
Anxiety
25%
Vomiting
25%
Dysphagia
23%
Hematuria
21%
Dyspnea
17%
Chills
17%
Edema limbs
17%
decreased WBC count
17%
Weight gain
15%
Gastroesophageal reflux disease
15%
Insomnia
13%
Bloating
13%
Depression
11%
Urinary frequency
11%
Neutropenia
11%
Cough
11%
Alopecia
9%
Paresthesia
9%
Hypertension
9%
Dysgeusia
9%
decreased platelets
8%
Abdominal distension
8%
Decreased white blood cell count
8%
Fever
8%
Thromboembolic event
8%
Sepsis
8%
Dizziness
8%
Malaise
6%
Dyspepsia
6%
Proteinuria
6%
Urinary tract infection
6%
Dry mouth
6%
decreseaed neutrophill count
6%
Neuropathy
6%
Hiccups
6%
Shortness of Breath
6%
Pain in extremity
6%
Anorexia
6%
HIGH ALKALINE PHOSPHATASE
6%
Acute kidney injury
4%
Abdominal Pain
4%
Hernia
4%
Dehydration
4%
H.Pylori Infection
4%
Dry skin
4%
Pneumonitis
4%
Colitis
4%
Palpitations
4%
Myelosuppression
4%
tachycardia
4%
Blurred vision
4%
Gastric hemorrhage
4%
Gastrointestinal pain
4%
Weakness
4%
Obesity
4%
Peripheral motor neuropathy
4%
Nocturia
4%
Hoarseness
4%
Vaginal hemorrhage
4%
increase mucus production
4%
Pleural effusion
4%
Headache
4%
Cold
4%
Early Satiety
4%
Weight Change
4%
Febrile neutropenia
4%
Non-cardiac chest pain
2%
extensive peritoneal carcinomatosis
2%
Epigastric discomfort
2%
Urinary retention
2%
Urinary incontinence
2%
Rib Pain (left side)
2%
Pain in anterior ribs
2%
increase sputum production
2%
Abdominal Tenderness
2%
Hypercholesterolemia
2%
oral thrush
2%
BRUISING
2%
Hypoxia
2%
right eye dimness
2%
decreased urine output
2%
Darkening of skin surrounding nasal areas
2%
arthralgia
2%
myalgia
2%
bone metastasis
2%
Flushing
2%
Hypercholesteremias
2%
sound in ear
2%
Hypothyroidism
2%
Right eye Pressure
2%
Right Upper Quadrant Pain
2%
biopsy site sore and numb
2%
Vitamin D deficiency
2%
hypercholesterolemia
2%
Diabetes
2%
Pneumonia
2%
peripheral vascular disease
2%
Syncope
2%
Gastric Hemorrhage
2%
Heart Block
2%
Hypokalemia
2%
Ascites
2%
Complete heart block
2%
Heart Disease (Organic)
2%
Hearing impaired
2%
Glaucoma
2%
erythema at the bottom of eyelids
2%
Esophageal fistula
2%
Gastric perforation
2%
Gastric ulcer
2%
Gastritis
2%
Mucositis oral
2%
Increased Eructation
2%
Heartburn
2%
Increasing Epigastric Pain
2%
Infusion related reaction
2%
uremia
2%
dehydration
2%
Itching
2%
HYPOALBUMINEMIA
2%
general discomfort
2%
Neuropathy to Extremities
2%
Swelling from Contrast Dye
2%
Discharge from Feeding Tube
2%
abdominal cramping
2%
Thrush
2%
Cholecystitis
2%
Elevate Liver Functions
2%
Splenic Vein Thrombosis
2%
mild jaundice
2%
Allergy to Penecillin
2%
pneumonia
2%
Elevated ANC
2%
Hyponatremia
2%
Hypophosphatemia
2%
vitamin B12 defeciency
2%
Iron defeciency
2%
Difficulty Feeding
2%
shallow white-based ulcer on L Lower buccal mucosa near border of lip
2%
reduced dexterity (right hand)
2%
brain metastases
2%
right arm spasms
2%
Stroke
2%
Altered Mental Status
2%
night sweats
2%
Hemoglobinuria
2%
Pyuria
2%
Dysuria
2%
overactive bladder
2%
renal failure
2%
increase in size of right testis
2%
post menopausal vaginal bleeding
2%
Aspiration
2%
Atelectasis
2%
Pulmonary embolism
2%
rales at the bases
2%
COPD exacerbation
2%
increased mucus
2%
Decreased breathing sounds over Left Lower Lung Field
2%
Postnasal drip
2%
Sleep apnea
2%
eczemarous dermatitis with eosinophilic folliculitis
2%
rosacia
2%
Chills/ Sweats
2%
psoriasis flare
2%
Skin Changes
2%
scatter petechiae
2%
portal vein thrombosis
2%
UROSEPSIS
2%
left ureteral stricture
2%
Pruritic maculaopapular rash LUQ
2%
bloody nose
2%
Puncture Wound Foot
2%
ecchymotic rash on hands
2%
Stomach pain
2%
mouth sore
2%
hiatus hernia syndrome
2%
epigastralgia
2%
Fall
2%
Vitamin D3 defeciency
2%
Lower extremity chills at night
2%
Tumor pain
2%
TINGLING IN HANDS
2%
vocal chord paralysis
2%
Hallucinations
2%
Apathy
2%
Esophageal pain
2%
Melena (black feces)
2%
Night Sweats
2%
right upper quadrant pain
2%
Urinary tract pain
2%
flu
2%
Lightheadedness
2%
Elevated CEA
2%
Flu like symptoms
2%
Infusion site extravasation
2%
Increased generalized weakness
2%
Pain
2%
Renal Failure
2%
Urinary Tract Obstruction
2%
Disseminated intravascular coagulation
2%
Leuocytosis
2%
Lymphadenopathy
2%
Left Neck Adenopathy
2%
Epistaxis (nose bleeds)
2%
vision change
2%
difficulty swallowing
2%
pyloric stenosis
2%
early satiety
2%
left upper quadrant pain
2%
bloody stools
2%
Localized edema
2%
Abrasion on R forearm after CT Scan
2%
hypersensitivity to oxaliplatin
2%
vasogenic edema
2%
BLE Edema
2%
moon face
2%
Hypocalcemia
2%
new left cervical and supraclavicular adenopathy of the axilla
2%
Brain Metastases
2%
Chronic kidney disease
2%
Cystitis noninfective
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Taxane naïve)
Arm B (Prior Taxane Therapy)
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
2,967 Previous Clinical Trials
1,804,683 Total Patients Enrolled
95 Trials studying Prostate Cancer
29,621 Patients Enrolled for Prostate Cancer
AstraZenecaIndustry Sponsor
4,259 Previous Clinical Trials
288,593,783 Total Patients Enrolled
59 Trials studying Prostate Cancer
27,403 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,434 Total Patients Enrolled
26 Trials studying Prostate Cancer
16,878 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated for prostate cancer with specific drugs.I am allergic to olaparib, carboplatin, or cabazitaxel.I am a man aged 18 or older.My prostate cancer diagnosis was confirmed through lab tests.I can perform daily activities with minimal assistance.I am willing and able to follow the study's treatment and visit schedule.I cannot swallow pills or have stomach issues affecting medication absorption.I don't have uncontrolled brain tumors or spinal issues affecting my nerves.I agree to participate in genetic research, but understand I can still be part of the study without it.I agree to provide tissue samples for study purposes.My cancer is getting worse, shown by tests or new symptoms.I agree to use birth control and extra protection if my partner can have children.I am diagnosed or suspected to have a blood disorder or leukemia.I haven't had cancer treatment in the last 5 years, except for certain skin or in-situ cancers.My cancer did not respond to more than 2 chemotherapy treatments for prostate cancer.I have recovered from side effects of cancer treatment, except for specific prostate cancer therapies.I am not currently using strong or moderate drugs that affect liver enzymes.I don't have any ongoing infections that aren't under control.My prostate cancer is resistant to hormone therapy and is worsening, but my PSA levels are not rising.I can swallow pills whole.I do not have any health or mental conditions that would make this study unsafe for me.I am undergoing treatment to lower my testosterone levels below 50 ng/dL.I have lasting side effects from cancer treatment, but not hair loss.I have active hepatitis or chronic liver disease.I have had lung inflammation or widespread lung disease not caused by cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Cabazitaxel + Carboplatin
- Group 2: Observation Only
- Group 3: Olaparib Maintenance
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the margin of safety for Cabazitaxel?
"While there is some data supporting the safety of Cabazitaxel, it received a score of 2 because there is currently no clinical evidence to support its efficacy."
Answered by AI
What are the primary medical conditions that Cabazitaxel has been shown to improve?
"Cabazitaxel can be used as a form of treatment for thyroiditis, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."
Answered by AI
Are we still accepting participants for this research study?
"The website clinicaltrials.gov says that this particular trial is not looking for new patients at the moment. It began on October 3rd, 2017 and was most recently updated April 2nd, 2021. There are currently 5136 other trials that are open to participants if you're interested in taking part in medical research."
Answered by AI
What is the history of Cabazitaxel in previous medical trials?
"At the moment, 1240 studies are running that involve Cabazitaxel with 340 of those being in Phase 3. The majority of these trials are taking place in Shanghai, but there are 69116 locations total where these kinds of trials are occurring."
Answered by AI
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