Bad.Klin. Dozylna wit.C + Docetaxel w przerzutowym PCa

Bad.Klin. Dozylna wit.C + Docetaxel w przerzutowym PCa

Nieprzeczytany postautor: wiatger » 17 sie 2018, 20:28

Amerykanski portal PROSTATEPEDIA opublikował ciekawy wywiad z dr Paller, onkologiem z Johns Hopkins University School of Medicine (USA), która interesuje się rygorystyczną oceną naturalnych produktów w leczeniu raka.
Tytuł wywiadu:

"Clinical Trial: Intravenous Vitamin C + Taxotere (Docetaxel)"

W wywiadzie tym dr Paller mówi, że dowiedziała się o randomizowanym badaniu, które wykazało, że podawanie dożylne wysokich dawek kwasu askorbinowego (witaminy C) u pacjentek z rakiem jajnika w połączeniu ze standardową chemioterapią zmniejszało toksyczność chemioterapii, a także umożliwiało pacjentkom otrzymanie większej liczby cykli chemioterapii, co wiązało się z dłuższym całkowitym przeżyciem.

Z inicjatywy Prostate Cancer Foundation podjęła badania nad rolą witaminy C w leczeniu raka prostaty, które zainicjowano na grupie 60 pacjentów.
Badanie jest randomizowane i kontrolowane przy pomocy placebo. Pacjentom z przerzutowym rakiem prostaty, wlewy dożylne kwasu askorbinowego (lub placebo) podawane są dwa razy w tygodniu pomiędzy cyklami chemioterapii, prowadzonej za pomocą Taxotere (Docetaxel).


Oryginał doniesienia pod tym linkiem:

1. Twoj link nie dziala - jesli masz dlugi link uzyj tiny.pl do jego skrocenia.
2. Nie tlumacz na polski nazw zagranicznych organizacji - Twoja "Fundacja Raka Prostaty" (teraz zmieniona przeze mnie na angielski oryginal) wprowadzila spore zamieszanie... -zb
ur. 1943. Od 2011 (PSA 1,87 ng/ml) leczenie BPH (Omnic Ocas). 02.2015 – PSA 4,12 ng/ml; TRUS, MRI miednicy z kontrastem: niejednorodne wzmocnienie tkanki gruczołowej części centralno-lewobocznej prostaty - podejrzenie zmiany npl gruczołu krokowego. 10.2016 – tPSA 6,19 ng/ml; fPSA 0,54 ng/ml; DRE: wyczuwalny guzek. 12.2016 – PSA 7,71 ng/ml; mpMRI: po lewej stronie ognisko hipointensywne, cechy infiltracji lewych pęcherzyków nasiennych. Miednica bez adenopatii- wysokie podejrzenie naciekającego raka stercza, PI-RADS 5. 02.01.2017 biopsja : płat prawy - w jednym z bioptatów mikroognisko raka gruczołowego ; płat lewy - rak gruczołowy, Gleason 8 (4+4). Naciekanie nerwów niewidoczne. Rtg klatki –b. z., Scyntygrafia kośćca – b. z., Usg - b.z. Od 18.01.17 Flutamid 3x250mg; 02.17 PSA 2,44 ng/ml 31.01.17 Eligard 22,5 mg. 14.02.17 Flutamid stop.20.03.17 tPSA 0,786 ng/ml. 29.03.17 rozpoczęcie TomoTherapy. 05.2017 Eligard 45 mg.25.05.17 zakończenie RT, tPSA 0,184 ng/ml, T 34 ng/dl; 10.17 tPSA 0,02 ng/ml, T 8,5 ng/dl; 11.17 Eligard 22,5; 02.18 tPSA <0,01, Diphereline 11,25;
05.18 tPSA <0,006, T 5,0 ng/dl, Diphereline 11,25; 08.18 tPSA <0,01, T 28 ng/dl (inne lab.), HT STOP!
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Re: Wlewy dożylne wit. C łącznie z chemioterapią w PCa

Nieprzeczytany postautor: zosia bluszcz » 18 sie 2018, 01:49


A Randomized Phase II Trial of Ascorbic Acid in Combination with Docetaxel in Men with Metastatic Prostate Cancer
April 12, 2017
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Ascorbic acid (vitamin C) is being used by complementary medicine practitioners to treat cancer, infections, and other conditions. Annual administration of more than 355,000 doses of intravenous (I.V.) ascorbic acid for more than 10,000 patients has been documented. Phase I and II clinical trials in 2012, 2013, and 2014 demonstrated safety and anti-tumor activity for high dose I.V. ascorbic acid.

These studies warranted testing the efficacy of I.V. ascorbic acid in randomized, placebo controlled clinical trials. At high concentrations, which can only be achieved with I.V. dosing but not oral use, ascorbic acid no longer acts as an anti-oxidant, but becomes a pro-oxidant that causes DNA damage and metabolic stress in tumor cells, provoking cell death. Normal cells have been shown to be unaffected by these reactions. This creates the specificity by which high dose I.V. ascorbic acid is selectively toxic to tumor cells but not normal tissues, and underlies the safety of I.V. ascorbic acid.

A recent study of high dose I.V. ascorbic acid in ovarian cancer patients indicated that ascorbic acid treatment combined with standard chemotherapy (paclitaxel) reduces certain toxicities associated with chemotherapy and might increase survival. Dr. Channing Paller is conducting a randomized phase II clinical trial comparing docetaxel plus I.V. ascorbic acid (1g/kg, 2 times per week) versus docetaxel plus I.V. fluid (placebo) in mCRPC patients. The primary outcomes will be PSA response and reduction of chemotherapy-related toxicities. Key secondary outcomes include radiographic progression free survival, safety, quality of life, and the need for dose reductions of docetaxel.

This clinical trial was launched in 2016 at Johns Hopkins University in Baltimore and Washington, and is currently opening at partnering sites including Thomas Jefferson University in Philadelphia, Karmanos Cancer Center in Detroit, and University Hospitals of Cleveland.
To find out if this clinical trial might be right for you or your patient, please call 410.955.8964 to schedule an appointment. Each patient must be seen in person to determine eligibility.

Contact: Channing Paller, MD

Full text detail on Clinical Trial

Partnering sites:
John Hopkins University
Thomas Jefferson University
Karmanos Cancer Center
University Hospitals of Cleveland
The Sidney Kimmel Comprehensive Cancer Center
Prostate Cancer Foundation

https://www.urotoday.com/recent-abstrac ... ancer.html
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Re: Wlewy dożylne wit. C łącznie z chemioterapią w PCa

Nieprzeczytany postautor: kinaszle » 18 sie 2018, 18:31

Ciekawe co wyjdzie! Bo duża dawka wit. C 1g/kg I.V. Chyba nikt z "portalowców" takiej dawki nie stosował.
ur.1961
02'2011 PSA 13,8 ng/ml (zapalenie prostaty) 03'2011 - 2,7 ng/ml
11'2012 - PSA 2,9 ng/ml
04'2015 - PSA 5,4 ng/ml 11'2015 - PSA 6,6 ng/ml[/b], Proscar 5mg 1x1
03'2016 - PSA 5,0 ng/ml 08'2016 - 3,4 ng/ml
09'2016 wymiana zastawki aortalnej /Encorton 70mg/dz / 3 miesiące z powodu odczynowego wysięku w osierdziu/ – dożywotnio Warfin VKA
12'2016 PSA 6,5 ng/ml, badanie urodynamiczne - hipotonia wypieracza
03'2017 - PSA 4,4 ng/ml 09'2017 - PSA 11 ng/ml
02'2018 PSA 10,7 ng/ml
03'2018 TURP – hist.-pat. Rak acinarny Gleason 9 /5+4/ Grade group 5. Npl w 50% skrawków, nacieka osłonkę nerwową
03'2018 TK przy lewych naczyniach biodrowych węzeł chłonny szer. 20mm
03'2018 SPECT
bez ognisk
03'2018 MRN - prostata niepowiększona. Zatarcie budowy strefowej, niejednorodna intensywność sygnału w cz. przejściowej i obwodowej lewej. Naciekanie dolnej cz.pęcherzyków nasiennych obustronnie. Pęcherz gładki. Węzły uwidocznione bzm.
03'2018 TES 5,5ng/ml 03'2018 HT – Bicalutamid 50mg
04'2018 – biopsja węzła - przerzut/naciek raka gruczołowego stercza PSA (+) ERG (+) T3N1M0.
04'2018 – Eligard 22,5mg 05'2018 PSA 1,13 ng/ml 05'2018 TES 0,25 ng/ml
04'06'2018 - 26'07'2018 RT - IMRT-IGRT 38 sesji = 78Gy/g w BCO,
Vit.C / co 2-gi tydzień RT) 6x15,0 iv, 6x30,0 iv, 3x25,0 2x25,0 iv
10'08'2018 TEST 0,07 ng/ml Vit.D3 50 ng/ml PSA 0,101 ng/ml

27.08.2018 Metformina 2 x 500mg
12'09'2018 – Eligard 22,5mg 10'09'2018 PSA 0,06 ng/ml (nadir?)
14'08'2018 Docetaxel (1) iv 99mg
19'09'2018 Vit.C 50,0 iv 26'09'2018 Vit.C 50,0 iv 03'10'2018 Vit.C 50,0 iv
01'10'2018 Metformina 850mg 2x1
04'10'2018 Docetaxel (2) iv 149 mg
24'10'2018 Vit.C 50,0 iv 25'10'2018 Docetaxel (3) 149mg
06'11'2018 Vit.D3 49,6 ng/ml PSA 0,105 ng/ml TES < 0.05 ng/ml

14'11'2018 Vit.C 50,0 iv
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Re: Bad.Klin. Dozylna wit.C + Docetaxel w przerzutowym PCa

Nieprzeczytany postautor: zosia bluszcz » 18 sie 2018, 23:10



Docetaxel With or Without Ascorbic Acid in Treating Patients With Metastatic Prostate Cancer
NCT02516670


Brief Summary:
This randomized phase II trial studies how well docetaxel works when given with or without ascorbic acid in treating patients with prostate cancer that has spread to other places in the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ascorbic acid (vitamin C) is a water-soluble vitamin that may help inhibit the growth of cancer cells. It is not yet known whether docetaxel works better when given with or without ascorbic acid in treating prostate cancer.

Detailed Description:

PRIMARY OBJECTIVES:

I. To compare the proportion of metastatic prostate cancer patients with a prostate specific antigen (PSA) decline of >= 50% over 8 cycles of docetaxel with ascorbic acid (Arm A) versus docetaxel with placebo (Arm B).
II. To compare the proportion of adverse events (fatigue, nausea, bone pain, and anorexia) experienced by metastatic prostate cancer patients receiving either docetaxel with ascorbic acid (Arm A) versus docetaxel with placebo (Arm B).

SECONDARY OBJECTIVES:
I. To assess radiographic progression free survival (rPFS) in patients with metastatic prostate cancer and compare between treatment arms.
II. To assess the proportion of high grade serious adverse events (fatigue, nausea, bone pain, and anorexia) in patients with metastatic prostate cancer and compare between treatment arms during 8 cycles of treatment.
III. To assess the proportion of high grade serious adverse events (all types) in patients with metastatic prostate cancer and compare between treatment arms during 8 cycles of treatment.
IV. To assess changes in quality of life measures as assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire.
V. To assess the proportion of metastatic prostate cancer patients requiring docetaxel dose reductions and compare between treatment arms during 8 cycles of treatment.

TERTIARY OBJECTIVES:
I. To determine whether ascorbic acid alters docetaxel exposure and compare between treatment arms.
II. To determine peak and trough ascorbic acid levels. III. As a pharmacodynamic measure of oxidant injury in vivo, measure F2-isoprostanes.

OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM A:
Patients receive docetaxel intravenously (IV) over 60 minutes on day 1 and ascorbic acid IV thrice weekly. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
ARM B:
Patients receive docetaxel IV over 60 minutes on day 1 and placebo IV over 60 minutes thrice weekly. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 6 months.


Criteria


Inclusion Criteria:
=> Have metastatic castration-resistant prostate cancer (prostate cancer progressing despite castrate levels of testosterone [< 50 ng/dL] using standard measures of progression defined by Prostate Cancer Working Group 2), are chemo-naïve for metastatic castration-resistant prostate cancer (mCRPC); patients must have symptomatic disease or visceral metastases or otherwise be eligible for docetaxel treatment per investigator judgment (e.g. for progression on imaging or rapidly rising PSA despite 2nd line hormonal treatment);
Note: Six cycles of prior docetaxel are allowed in hormone-sensitive disease, per Eastern Cooperative Oncology Group (ECOG) 3805 data and have been off of docetaxel for at least 12 months
=> Have a pathological diagnosis of prostate carcinoma
=> Patients may be receiving continuous hormonal ablation with surgical or medical castration with baseline testosterone < 50 ng/dL
=> Patient may be receiving bone targeted agents
=> Have evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and/or Prostate Cancer Working Group 2 (PCWG2) criteria
=> Have ECOG performance status 0-1
=> Have an estimated life expectancy > 4 months
=> Absolute neutrophil count >= 1500/mm^3
=> Platelets >= 100,000/mm^3
=> Hemoglobin >= 9 g/dL
=> Total bilirubin =< 1.0 upper limit of normal (ULN)
=> Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN
=> Creatinine =< 1.6 mg/dl (for patients with > 1.6 mg/dl, calculated or measured creatinine clearance must be >= 55 mL/minute [Cockcroft-Gault])
=> Men of reproductive potential and those who are surgically sterilized (i.e., postvasectomy) must agree to practice effective barrier contraception that has an expected failure rate of < 1% during and for 30 days after discontinuation of study treatment
=> If condoms are used as a barrier contraceptive, a spermicidal agent should be added to ensure that pregnancy does not occur
=> Have the ability to understand, and have given written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care

Exclusion Criteria:
=> Have had known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for CNS involvement for at least one week prior to trial treatment; patients with primary brain tumors are not eligible; however, as patients are completing abiraterone therapy, they will be allowed to continue up to 10 mg/day of prednisone
=> Have had prior chemotherapy for metastatic disease in castration-resistant prostate cancer (prior chemotherapy for hormone-sensitive disease, more than twelve months prior to registration, is acceptable)
=> Have had had surgery within four weeks of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement
=> Have had palliative radiation or biological cancer therapy within 2 weeks prior to the first dose of study drug
=> Have received other investigational drugs within 28 days prior to enrollment
=> Is expected to require any other form of systemic or localized antineoplastic therapy while on study
=> Patients who require frequent (several times a day) monitoring of their blood glucose or patients who have recently been hospitalized for glucose control
=> Are being treated with anticoagulation therapy (aspirin and nonsteroidal anti-inflammatory drugs [NSAIDS] are allowed)
=> The subject requires concomitant treatment with the following inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4):
=> Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin
=> Antifungals: itraconzaole, ketoconazole, voriconazole, fluconazole, posaconazole
=> Antidepressants: nefazodone
=> Antidiuretic: conivaptan
=> Anti-retrovirals: delaviridine or protease inhibitors (ritonavir, indinavir, lopinavir/ritonavir, saquinavir, nelfinavir) or cobicistat-boosted antiretrovirals
=> Gastrointestinal (GI): cimetidine, aprepitant
=> Hepatitis C: boceprevir, telaprevir
=> Miscellaneous: Seville oranges, grapefruit, or grapefruit juice and/or pummelos, star fruit, exotic citrus fruits, or grapefruit hybrids
=> Have 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
=> Has glucose-6-phosphate dehydrogenase (G6PD) deficiency
=> Have end stage renal disease
=> Has history of calcium oxalate stones
=> Has history of iron overload
=> Have a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies), hepatitis B, or hepatitis C infection

https://clinicaltrials.gov/ct2/show/NCT02516670
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Re: Bad.Klin. Dozylna wit.C + Docetaxel w przerzutowym PCa

Nieprzeczytany postautor: kinaszle » 19 sie 2018, 09:29

Rozumiem, że badanie trwa i nie ma jeszcze wstępnych wyników?
Pzdr

Tak wlasnie jest. -zb
ur.1961
02'2011 PSA 13,8 ng/ml (zapalenie prostaty) 03'2011 - 2,7 ng/ml
11'2012 - PSA 2,9 ng/ml
04'2015 - PSA 5,4 ng/ml 11'2015 - PSA 6,6 ng/ml[/b], Proscar 5mg 1x1
03'2016 - PSA 5,0 ng/ml 08'2016 - 3,4 ng/ml
09'2016 wymiana zastawki aortalnej /Encorton 70mg/dz / 3 miesiące z powodu odczynowego wysięku w osierdziu/ – dożywotnio Warfin VKA
12'2016 PSA 6,5 ng/ml, badanie urodynamiczne - hipotonia wypieracza
03'2017 - PSA 4,4 ng/ml 09'2017 - PSA 11 ng/ml
02'2018 PSA 10,7 ng/ml
03'2018 TURP – hist.-pat. Rak acinarny Gleason 9 /5+4/ Grade group 5. Npl w 50% skrawków, nacieka osłonkę nerwową
03'2018 TK przy lewych naczyniach biodrowych węzeł chłonny szer. 20mm
03'2018 SPECT
bez ognisk
03'2018 MRN - prostata niepowiększona. Zatarcie budowy strefowej, niejednorodna intensywność sygnału w cz. przejściowej i obwodowej lewej. Naciekanie dolnej cz.pęcherzyków nasiennych obustronnie. Pęcherz gładki. Węzły uwidocznione bzm.
03'2018 TES 5,5ng/ml 03'2018 HT – Bicalutamid 50mg
04'2018 – biopsja węzła - przerzut/naciek raka gruczołowego stercza PSA (+) ERG (+) T3N1M0.
04'2018 – Eligard 22,5mg 05'2018 PSA 1,13 ng/ml 05'2018 TES 0,25 ng/ml
04'06'2018 - 26'07'2018 RT - IMRT-IGRT 38 sesji = 78Gy/g w BCO,
Vit.C / co 2-gi tydzień RT) 6x15,0 iv, 6x30,0 iv, 3x25,0 2x25,0 iv
10'08'2018 TEST 0,07 ng/ml Vit.D3 50 ng/ml PSA 0,101 ng/ml

27.08.2018 Metformina 2 x 500mg
12'09'2018 – Eligard 22,5mg 10'09'2018 PSA 0,06 ng/ml (nadir?)
14'08'2018 Docetaxel (1) iv 99mg
19'09'2018 Vit.C 50,0 iv 26'09'2018 Vit.C 50,0 iv 03'10'2018 Vit.C 50,0 iv
01'10'2018 Metformina 850mg 2x1
04'10'2018 Docetaxel (2) iv 149 mg
24'10'2018 Vit.C 50,0 iv 25'10'2018 Docetaxel (3) 149mg
06'11'2018 Vit.D3 49,6 ng/ml PSA 0,105 ng/ml TES < 0.05 ng/ml

14'11'2018 Vit.C 50,0 iv
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Re: Bad.Klin. Dozylna wit.C + Docetaxel w przerzutowym PCa

Nieprzeczytany postautor: wiatger » 20 sie 2018, 18:35

Sądząc po ilości odsłon, temat cieszy się zainteresowaniem.
Ciekawe, czy okaże się, że prof. Pauling miał rację, lansując przyjmowanie dużych dawek wit. C także w chorobach nowotworowych.
ur. 1943. Od 2011 (PSA 1,87 ng/ml) leczenie BPH (Omnic Ocas). 02.2015 – PSA 4,12 ng/ml; TRUS, MRI miednicy z kontrastem: niejednorodne wzmocnienie tkanki gruczołowej części centralno-lewobocznej prostaty - podejrzenie zmiany npl gruczołu krokowego. 10.2016 – tPSA 6,19 ng/ml; fPSA 0,54 ng/ml; DRE: wyczuwalny guzek. 12.2016 – PSA 7,71 ng/ml; mpMRI: po lewej stronie ognisko hipointensywne, cechy infiltracji lewych pęcherzyków nasiennych. Miednica bez adenopatii- wysokie podejrzenie naciekającego raka stercza, PI-RADS 5. 02.01.2017 biopsja : płat prawy - w jednym z bioptatów mikroognisko raka gruczołowego ; płat lewy - rak gruczołowy, Gleason 8 (4+4). Naciekanie nerwów niewidoczne. Rtg klatki –b. z., Scyntygrafia kośćca – b. z., Usg - b.z. Od 18.01.17 Flutamid 3x250mg; 02.17 PSA 2,44 ng/ml 31.01.17 Eligard 22,5 mg. 14.02.17 Flutamid stop.20.03.17 tPSA 0,786 ng/ml. 29.03.17 rozpoczęcie TomoTherapy. 05.2017 Eligard 45 mg.25.05.17 zakończenie RT, tPSA 0,184 ng/ml, T 34 ng/dl; 10.17 tPSA 0,02 ng/ml, T 8,5 ng/dl; 11.17 Eligard 22,5; 02.18 tPSA <0,01, Diphereline 11,25;
05.18 tPSA <0,006, T 5,0 ng/dl, Diphereline 11,25; 08.18 tPSA <0,01, T 28 ng/dl (inne lab.), HT STOP!
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