Cyclophosphamide and Dexamethasone for the Treatment of Metastatic Castration Resistant Prostate Cancer

NCT05479578 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: UCDCC#301NCI-2022-05133P30CA093373
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial tests the safety and side effects of cyclophosphamide given together with dexamethasone in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Chemotherapy drugs, such as cyclophosphamide, 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. Giving low doses of cyclophosphamide daily may reduce side effects. Dexamethasone is a corticosteroid drug that is used to treat some of the problems caused by chemotherapy treatment. The combination of cyclophosphamide and dexamethasone may work better in treating patients with castration resistant prostate cancer.

Conditions

Castration-Resistant Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) V8

Outcome Measures

Primary Outcomes (2)

• Feasibility

  Feasibility, defined as \>= 80% of participants completing treatment, and safety as defined by Grade 3 or higher adverse events (AEs) observed per National Cancer Institute (NCI) Common Terminology Criteriafor Adverse Events (CTCAE 5.0) criteria

  Treatment initiation through treatment completion, an average of up to 4 years

• Incidence of adverse events

  Number of participants experiencing adverse events (AEs), both non treatment related and treatment related, classified by severity and graded.

  Treatment initiation through treatment completion, an average of up to 4 years

Secondary Outcomes (4)

• Total prostate-specific antigen (PSA) response rate

  From date of treatment initiation through PSA response (as defined by Prostate Cancer Working Group 2 [PCWG2]), an average of up to 4 years

• Time to no longer clinical benefit (NLCB)

  Treatment initiation through treatment completion, an average of up to 4 years

• Time to prostate-specific antigen (PSA) progression

  From date of treatment initiation to PSA progression (as defined by Prostate Cancer Working Group 2 [PCWG2]), an average of up to 4 years

• Time to radiographic progression free survival (rPFS)

  From date of treatment initiation to radiographic progression (as defined by Prostate Cancer Working Group 2 [PCWG2]) or date of death from any cause, whichever came first, an average of up to 4 years

Study Arms (1)

Treatment (cyclophosphamide, dexamethasone)

EXPERIMENTAL

Patients receive cyclophosphamide PO QD and dexamethasone PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Cyclophosphamide; Drug: Dexamethasone

Interventions

Cyclophosphamide DRUG

Given PO

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719

Treatment (cyclophosphamide, dexamethasone)

Dexamethasone DRUG

Given PO

Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex

Treatment (cyclophosphamide, dexamethasone)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to sign an informed consent form
• Ability to adhere to the study visit schedule and other protocol requirements
• Adults \>= 18 years of age at time of consent
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2
• Life expectancy \>= 3 months
• Histologically or cytologically confirmed prostate adenocarcinoma
• Metastatic status defined as at least 1 documented metastatic lesion on a bone scan, a computed tomography (computed tomography \[CT\] or CT/ positron emission tomography \[PET\]) scan, or a magnetic resonance imaging (MRI) scan
• Must have less than 50 ng/dL testosterone
• Must have demonstrated disease progression after treatment with 2 or more prior lines of therapies for castration resistant prostate cancer (CRPC), including one second generation androgen targeted agent (such as abiraterone or enzalutamide).
• PSA defined progression after most recent directed therapy. Progression is defined as PSA increase \>= 25% of baseline or absolute increase of \>= 2 ug/L on two PSA measurements at least 7 days apart
• Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L
• Platelet count \>= 100 x 10\^9/L
• Hemoglobin \>= 8 g/dL
• Total bilirubin level =\< 1.5 x the upper limit of normal (ULN) range
• Aspartate aminotransferase (AST) and alanine transaminase (ALT) levels =\< 2.5 × ULN or AST and ALT levels =\< 5 x ULN (for participants with documented metastatic disease to the liver)

You may not qualify if:

• Any condition that would prohibit the understanding or rendering of informed consent
• A history of any other active malignancy with progression and requiring treatment/intervention, with the exception of cutaneous malignancies such as basal cell carcinoma, squamous cell carcinoma, melanoma, or the type of malignancy being studied in this protocol
• Participants with urinary outflow obstruction that has not been treated or managed with either indwelling catheter or self-catheterization
• Severe untreated infection that in the opinion of the investigator would interfere with participant safety or compliance on trial within 28 days prior to enrollment
• Any condition, including concomitant disease, additional malignancies, laboratory abnormalities, or psychiatric illness, that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
• Use of systemic therapy for the treatment of prostate adenocarcinoma within 2 weeks of initiating study treatment

Sponsors & Collaborators

• Rashmi Verma, MD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Cyclophosphamide; Dexamethasone; Calcium Dobesilate; auricularum; dexamethasone acetate; dexamethasone 21-phosphate

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Rashmi Verma, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 29, 2022
• Study Start: June 29, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

US (1)