Oxaliplatin and Pemetrexed Disodium in Treating Patients With Refractory Hormone-Resistant Prostate Cancer

NCT01338792 | Completed Phase 2 Results DMC

• 2 other identifiers: 4P-05-7NCI-2011-00500
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well giving oxaliplatin and pemetrexed disodium together works in treating patients with refractory hormone-resistant prostate cancer. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving oxaliplatin together with pemetrexed disodium may kill more tumor cells.

Conditions

Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Best Overall Response

  For patients with measurable disease, the RECIST 1.0 criteria was used to determine response. Complete Response = disappearance of all target lesions, Partial Response = greater or equal to 30% decrease in sum of longest diameter or target lesions, Stable Disease = \<30% decrease or \<20% increase, Progressive Disease = greater or equal to 20% increase in longest diameter of target lesions. For patients who do not have measurable disease by RECIST, the response was based on PSA response defined by Prostate Cancer Working Group criteria (1999) as 50% reduction in PSA confirmed on a second measurement at least 4 weeks later.

  RECIST evaluation: Baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. PSA evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 year

Secondary Outcomes (2)

• Time to Disease Progression and Overall Survival

  Baseline, after every 2 courses, and then every 6 months after off-study (RECIST) until progression; or baseline, day 1 of each course, at the final evaluation, and then every 6 months after off-study (PSA) until progression

• Number of Participants With Serious Adverse Events (SAEs)

  Baseline, days 1 and 7 of each course, and at last evaluation, up to 1 year

Study Arms (1)

Treatment (chemotherapy and enzyme inhibitor)

EXPERIMENTAL

Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Drug: oxaliplatin; Drug: pemetrexed disodium; Other: questionnaire administration; Other: laboratory biomarker analysis; Genetic: reverse transcriptase-polymerase chain reaction; Genetic: polymorphism analysis

Interventions

oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP

Treatment (chemotherapy and enzyme inhibitor)

pemetrexed disodium DRUG

Given IV

Also known as: ALIMTA, LY231514, MTA

Treatment (chemotherapy and enzyme inhibitor)

questionnaire administration OTHER

Ancillary studies

Treatment (chemotherapy and enzyme inhibitor)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (chemotherapy and enzyme inhibitor)

reverse transcriptase-polymerase chain reaction GENETIC

Correlative studies

Also known as: RT-PCR

Treatment (chemotherapy and enzyme inhibitor)

polymorphism analysis GENETIC

Correlative studies

Treatment (chemotherapy and enzyme inhibitor)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed prostate cancer
• Measurable disease on computed tomography (CT) or evaluable disease on bone scan with an elevated PSA
• For patients who did not initially present with metastatic disease, definitive treatment with either radical prostatectomy or external beam radiation is permitted
• Documented progression on (a) two prior hormone treatments AND (b) one or two chemotherapy regimens
• Documented progression on two prior hormone therapies is defined as orchiectomy followed by anti-adrenal medication upon progression OR gonadotropin-releasing hormone (GnRH) analog +/- androgen receptor blocker with addition or subtraction upon progression; castrate level of testosterone must be documented at study entry
• Documented progression on taxane-based chemotherapy; in addition, patients may have failed a second prior chemotherapy regimen
• Palliative radiation therapy for metastatic disease is allowed only if less than 25% of total body bone marrow was irradiated; 28 days must have elapsed since completion of radiation therapy (RT) with bone marrow recovery; soft tissue disease irradiated in the prior 2 months may not be designated as measurable disease
• ECOG performance score of 0-2
• Absolute neutrophil count (ANC) \>= 1500/uL
• Platelet count \>= 100,000/uL
• Creatinine clearance \>= 45 mL/min
• Serum total bilirubin =\<1.5 mg/dL
• Alkaline phosphatase =\< 3x the upper limit of normal (ULN) for the reference lab (=\< 5x the ULN for patients with known hepatic metastases) and no upper limit for patients with known bone metastases
• Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) =\< 3x the ULN for the reference lab (=\< 5x the ULN for patients with known hepatic metastases)
• Patients must be recovered from both acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy

You may not qualify if:

• Active infection or with a fever \>= 38.5 degrees Celsius (C) within 3 days of the first scheduled protocol treatment
• Patients with brain metastases
• Prior malignancy within the past 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or superficial bladder cancer
• Known hypersensitivity to any of the components of oxaliplatin or pemetrexed
• Received radiotherapy to more than 25% of their bone marrow, or patients who received any radiotherapy within 4 weeks of entry
• Received treatment with strontium
• Receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment
• Life expectancy \< 6 months
• Peripheral neuropathy \>= Grade 2
• Any other medical condition, including mental illness or substance abuse
• History of allogeneic transplant
• Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated, or both)
• Inability to stop nonsteroidal anti-inflammatory drugs (NSAIDS) for a period of 2 days before, the day of, and 2 days following administration of Alimta; 5 days before, the day of, and 2 days following administration of Alimta for long-acting NSAIDS

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• Dorff TB, Tsao-Wei DD, Groshen S, Boswell W, Goldkorn A, Xiong S, Quinn DI, Pinski JK. Efficacy of oxaliplatin plus pemetrexed in chemotherapy pretreated metastatic castration-resistant prostate cancer. Clin Genitourin Cancer. 2013 Dec;11(4):416-22. doi: 10.1016/j.clgc.2013.07.011. Epub 2013 Oct 4.

  PMID: 24099865 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Oxaliplatin; Pemetrexed; Reverse Transcriptase Polymerase Chain Reaction; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; DNA Fingerprinting

Results Point of Contact

• Title: Jacek Pinski, MD
• Organization: USC Norris Comprehensive Cancer Center

pinski_j@ccnt.usc.edu

323-865-3900

Study Officials

• Jacek Pinski

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 20, 2011
• Study Start: June 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: March 10, 2014
• Results First Posted: December 11, 2013

Record last verified: 2014-02

Locations

US (1)