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A Phase II Trial of Oxaliplatin and Pemetrexed in Hormone Refractory Prostate Cancer

Phase 2
18 Years
Not Enrolling
Hormone-resistant Prostate Cancer, Recurrent Prostate Cancer

Thank you

Trial Information

A Phase II Trial of Oxaliplatin and Pemetrexed in Hormone Refractory Prostate Cancer

PRIMARY OBJECTIVES: I. To determine the response rate by Response Evaluation Criteria In
Solid Tumors (RECIST) criteria, prostate-specific antigen (PSA) response by the PSA Working
Group criteria, and overall clinical benefit defined by summation of RECIST complete
responses (CR) plus RECIST partial responses (PR) plus PSA PRs. SECONDARY OBJECTIVES: I.
To determine time to progression in patients with hormone-refractory prostate cancer (HRPC)
receiving oxaliplatin and pemetrexed. II. To describe the safety profile of this treatment.
III. Pain response will be evaluated in an exploratory manner. IV. Undertake a pilot
analysis of excision repair cross-complementing 1 (ERCC1) expression levels and
polymorphisms, looking at their ability to predict response to platinum therapy. OUTLINE:
Patients receive oxaliplatin intravenously (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. After completion of study treatment, patients are followed up
every 6 months.

Inclusion Criteria:

- 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

- Patients or their legal representatives must be able to read, understand and provide
informed consent to participate in the trial

- Men of childbearing potential must consent to use barrier contraception while on
treatment and for 90 days thereafter

- Patients with pleural or peritoneal effusions are eligible

- Willingness and ability to take vitamin supplementation and steroid premedication as
specified in protocol

- Patients with superficial bladder cancer or skin cancer who have second malignancy
within 5 years which was removed with curative intent

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response in patients with HRPC who have received taxane-based chemotherapy

Outcome Description:

For patients with measurable disease, the RECIST criteria will be used to determine response; for patients who do not have measurable disease by RECIST, the response will be based on PSA

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Jacek Pinski

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

June 2006

Completion Date:

December 2012

Related Keywords:

  • Hormone-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Prostatic Neoplasms



USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800