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Hormone-Resistant Prostate CancerPhase 2NCT02516670

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

A Phase 2 study testing Ascorbic Acid, Docetaxel and Laboratory Biomarker Analysis in people with Hormone-Resistant Prostate Cancer and Metastatic Prostate Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Ascorbic Acid, Docetaxel and Laboratory Biomarker Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
6 sitesUnited States
Study dates
20 Jun 2016to 14 Oct 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Anne Arundel Health System, Research Institute

    Annapolis, Maryland, 21401

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • University Hospitals of Cleveland Seidman Cancer Center

    Cleveland, Ohio, 44106

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

Official title: A Randomized Phase 2 Trial of Ascorbic Acid in Combination With Docetaxel in Men With Metastatic Prostate Cancer

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.

Being tested
Ascorbic Acid, Docetaxel, Laboratory Biomarker Analysis, Pharmacological Study, Placebo
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ascorbic AcidDietary supplement

    Also called 2-(1,2-dihydroxyethyl)-4,5-dihydroxy-furan-3-one, Asorbicap, C Vitamin, C-Long

    Given IV

  • DocetaxelDrug

    Also called RP56976, Taxotere, Taxotere Injection Concentrate

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pharmacological StudyOther

    Correlative studies

  • PlaceboOther

    Also called placebo therapy, PLCB, sham therapy

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT02516670
Study groupRoleWhat they receive
Arm A (docetaxel, ascorbic acid)ExperimentalPatients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Receives: Dietary Supplement: Ascorbic Acid; Drug: Docetaxel; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Quality-of-Life Assessment
Arm B (docetaxel, placebo)Placebo comparatorPatients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Docetaxel; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Placebo; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participates With a Decline in Prostate-specific Antigen From Their Baseline Measurement

    prostate-specific antigen decline will be defined as ≥ 50% from baseline measurement

    Measured: up to 24 weeks

  2. Number of Participants With Adverse Events

    Number of participants experiencing fatigue, nausea, bone pain, and anorexia as defined by CTCAE 4.0

    Measured: Up to 30 days after the last dose of study drug

Secondary outcomes (5)

  1. Average Number of Times Docetaxel Had Dose Reductions

    The number of dose reductions and total number of completed cycles will be summarized by study arm.

    Measured: Up to 24 weeks

  2. Number of Serious Adverse Events

    Number of serious adverse events of all types as defined by Common Terminology Criteria for Adverse Events 4.0.

    A serious adverse event is an undesirable sign, symptom, or medical condition that:

    • Results in death
    • Is life threatening
    • Requires inpatient hospitalization or causes prolongation of existing hospitalization for >24 hours
    • Results in persistent or significant disability/incapacity
    • Is a congenital anomaly/birth defect
    • Is an important medical event

    Measured: Up to 30 days after last dose of study drug

  3. Number of Participates Experiencing Serious Adverse Events (SAE)

    Number of serious adverse events defined as grade 3 or higher (fatigue, nausea, bone pain, and anorexia) in participates as defined by CTCAE 4.0

    Measured: Up to 24 weeks

  4. Change in Quality of Life (QoL) as Measured by the FACT-P Questionnaire

    The (FACT-P) is made up of 39 question, with the total score ranging between 0 and 156 with 0 being the best and 156 as the worst.

    Measured: Up to course 6 of therapy (18 weeks)

  5. Radiographic Progression Free Survival (rPFS)

    To determine the rPFS of participates that receive at least one dose of ascorbic acid compared to those who received placebo

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2015 (estimated)
  2. Study start20 Jun 2016
  3. Primary completion31 Jul 2021
  4. Study completion14 Oct 2021

Why it stopped: insufficient clinical response per DSMB

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02516670
Sponsor's protocol ID
J15106
Other IDs
NCI-2015-01169, IRB00070691, J15106, P30CA006973
Status last verified
Jun 2023
First submitted
4 Aug 2015
Last updated
7 Jun 2023
Data monitoring committee
Yes

Publications

  • Paller CJ, Zahurak ML, Mandl A, Metri NA, Lalji A, Heath E, Kelly WK, Hoimes C, Barata P, Taksey J, Garrison DA, Patra K, Milne GL, Anders NM, Nauroth JM, Durham JN, Marshall CH, Markowski MC, Eisenberger MA, Antonarakis ES, Carducci MA, Denmeade SR, Levine M. High-Dose Intravenous Vitamin C Combined with Docetaxel in Men with Metastatic Castration-Resistant Prostate Cancer: A Randomized Placebo-Controlled Phase II Trial. Cancer Res Commun. 2024 Aug 1;4(8):2174-2182. doi: 10.1158/2767-9764.CRC-24-0225.

    PubMed 39076107

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ascorbic Acid, Docetaxel and Laboratory Biomarker Analysis in people with Hormone-Resistant Prostate Cancer and Metastatic Prostate Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participates With a Decline in Prostate-specific Antigen From Their Baseline Measurement (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02516670, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.

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