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Anti-microtubule agent
Chemotherapy for Kidney Cancer
Phase 2
Waitlist Available
Research Sponsored by Theradex
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Locally advanced OR Metastatic OR Unresectable
Measurable disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will study the effectiveness of DHA-paclitaxel in treating kidney cancer.
Who is the study for?
This trial is for adults over 18 with advanced, metastatic, or inoperable kidney cancer. They must have measurable disease, no brain metastasis, good performance status (ECOG 0-1), adequate blood counts and liver function, controlled heart rhythm without recent heart attack, no severe infections or psychiatric disorders that would interfere with the study. Participants should not be pregnant/nursing and must use effective contraception.Check my eligibility
What is being tested?
The effectiveness of a chemotherapy drug called DHA-paclitaxel is being tested on patients with advanced kidney cancer. This Phase II trial aims to see how well it stops tumor cells from growing by preventing them from dividing.See study design
What are the potential side effects?
DHA-paclitaxel may cause side effects such as allergic reactions during infusion, lowered blood cell counts increasing infection risk and bleeding problems, nerve damage leading to numbness or tingling sensations (neuropathy), fatigue, nausea and hair loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer cannot be removed by surgery and has spread.
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My cancer can be measured by tests.
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I do not have a serious infection needing IV treatment.
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I do not have any serious or unstable health conditions.
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My cancer has not spread to my brain.
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I am fully active or can carry out light work.
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My creatinine level is 2.5 mg/dL or lower.
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I am 18 years old or older.
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My kidney cancer diagnosis was confirmed through lab tests.
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My heart rhythm is normal, and I haven't had a heart attack in the last 3 months.
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I don't have severe nerve damage, uncontrolled seizures, or spinal cord issues.
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My liver function tests are within the required limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
TheradexLead Sponsor
33 Previous Clinical Trials
1,562 Total Patients Enrolled
Ronald M. Bukowski, MDStudy ChairThe Cleveland Clinic
4 Previous Clinical Trials
71 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer cannot be removed by surgery and has spread.My cancer can be measured by tests.I have had skin cancer or cervical cancer treated without recurrence, or any cancer treated surgically over 5 years ago without coming back.I do not have a serious infection needing IV treatment.I am fully active or can carry out light work.My creatinine level is 2.5 mg/dL or lower.I've been on a stable dose of bisphosphonates for over 30 days and am not on any other cancer treatments.My cancer has not spread to my brain.I do not have any serious or unstable health conditions.I haven't taken hormonal therapy for at least 28 days and am not currently on it.It's been over 28 days since my last major radiotherapy session, and I'm not currently undergoing any.It has been more than 14 days since my last major surgery.I will use birth control during and for 6 months after the study.I am 18 years old or older.My kidney cancer diagnosis was confirmed through lab tests.It has been over 28 days since my last immunotherapy, and I am not currently on immunotherapy.My heart rhythm is normal, and I haven't had a heart attack in the last 3 months.I haven't had chemotherapy for advanced disease, taxanes, or any chemo in the last 28 days.I don't have severe nerve damage, uncontrolled seizures, or spinal cord issues.My liver function tests are within the required limits.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrolment opportunities available to participants at this juncture?
"Per clinicaltrials.gov, this medical research has ceased accepting patients since its last edit on July 23rd 2008. Despite that, 423 other studies are presently searching for candidates to partake in their trials."
Answered by AI
Is this therapeutic procedure free from any substantial risks?
"Despite the lack of supporting evidence for its efficacy, our team at Power assigned a value of 2 to this treatment's safety due to available Phase 2 clinical trial data."
Answered by AI
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