Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-… (NCT01497925) | Clinical Trial Compass
CompletedPhase 1
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
United States43 participantsStarted 2011-09-06
Plain-language summary
This Phase I trial combines ADI-PEG 20 with docetaxel in patients with advanced solid tumors with emphasis on castration resistant prostate cancer (CRPC). The investigators hypothesize that the combination will result in greater tumor cytotoxicity with an acceptable toxicity profile (i.e., manageable side effects) in cancer patients due to the unique mechanism of action of ADI-PEG 20. The investigators also hypothesize that the combination of ADI-PEG 20 and docetaxel will result in enhanced tumor cell apoptosis in part due to autophagy and that this will be particularly relevant in CRPC.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. For the dose-escalation phase, patients must have cytologically or histologically proven advanced malignant solid tumors, with emphasis on CRPC.
. Patients must be 18 years of age or older.
. Patients must have a Zubrod (ECOG) performance status of 0-2.
. Patients must have an estimated survival of at least 3 months.
. Any prior chemotherapy must have been completed at least 4 weeks prior to start of treatment. Prior radiation must have been completed at least 2 weeks prior to start of therapy. Patients must have recovered from acute reversible side effects of prior chemotherapy regimens or radiotherapy to \< grade 1 (excluding alopecia, lymphopenia, and hyperglycemia) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Adverse Events
Timeframe: 6 months
2
Efficacy, as determined by objective response measures
. Radiographs (Xrays, CT scans, etc) to follow disease response or progression must have been completed within 28 days prior to registration.
. Patients must have adequate renal function as documented by a calculated creatinine clearance of \> 45 ml/min (see Appendix for formula for calculating creatinine clearance).
. Patients must have adequate liver functions: AST and ALT \< 2.5 X upper limit of normal, and bilirubin \< upper limit of normal.
Exclusion criteria
. Pregnant or breastfeeding women. The effects of these drugs on the unborn fetus are unknown. Documentation of a negative serum pregnancy test is required for all women of reproductive potential.
. Patient has a clinically significant concurrent illness. Patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection.
. Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered. Also, a patient may not enroll in such clinical trials while participating in this study.
. Patient has a history of allergy or hypersensitivity to the study drugs or a taxane.
. Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
. Prior therapy with ADI-PEG 20 or docetaxel.
. Allergy to pegylated compounds or study drugs.
. Patient has a clinically significant concurrent illness. Patients must not have a serious intercurrent medical or psychiatric illness, including serious active infection.