Phase 2
N=47
Oxaliplatin and Pemetrexed Disodium in Treating Patients With Refractory Hormone-Resistant Prostate Cancer
Hormone-resistant Prostate Cancer · Recurrent Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01338792 ↗Enrolled (actual)
47
Serious AEs
74.5%
Results posted
Dec 2013
Primary outcome: Primary: Best Overall Response — 0; 14; 21; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- oxaliplatin (Drug); pemetrexed disodium (Drug); questionnaire administration (Other); laboratory biomarker analysis (Other); reverse transcriptase-polymerase chain reaction (Genetic); polymorphism analysis (Genetic)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Southern California
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response |
0; 14; 21; 8; 4 | — |
| SECONDARY Time to Disease Progression and Overall Survival |
12.0; 5.8; 5.4 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
35 | — |
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.
Eligibility Criteria
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 = = 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 = 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
Data sourced from ClinicalTrials.gov (NCT01338792). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.