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

  • STATUS
    Recruiting
  • End date
    Jan 14, 2030
  • participants needed
    69
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 14 June 2021
cancer
absolute neutrophil count
carcinoma
testosterone
metastasis
neutrophil count
tumor cells
docetaxel
metastatic prostate cancer
castration-resistant prostate cancer
metastatic castration-resistant prostate cancer

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.

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.

Details
Condition Metastatic Prostate Cancer, Prostate Cancer Metastatic, Stage IV Prostate Cancer, Hormone-Resistant Prostate Cancer, Metastatic Prostate Carcinoma
Treatment laboratory biomarker analysis, quality-of-life assessment, docetaxel, Placebo, pharmacological study, Ascorbic acid
Clinical Study IdentifierNCT02516670
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on14 June 2021

Eligibility

Yes No Not Sure

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-nave 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)
Have a know active uncontrolled hepatitis B, or hepatitis C infection
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