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Vinca Alkaloids

Vinorelbine for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No significant ventricular arrhythmia requiring drug control

No venous access problems that would preclude blood sampling

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is comparing two different chemotherapy drugs to see which is more effective in treating patients with solid tumors.

Who is the study for?

Adults aged 18-75 with metastatic or advanced solid tumors may qualify for this trial if they have a life expectancy over 3 months, no severe infections recently, and their major organs are functioning well. They must not be pregnant or nursing and agree to use contraception. Those with certain heart, lung, gastrointestinal issues, uncontrolled medical conditions, or recent serious health events cannot participate.Check my eligibility

What is being tested?

This phase I trial is testing two different dosing regimens of vinorelbine to see which one is more effective in treating patients with metastatic or advanced solid tumors. Vinorelbine is a chemotherapy drug that aims to stop cancer cells from growing by interfering with cell division.See study design

What are the potential side effects?

Vinorelbine can cause side effects like nausea, constipation or diarrhea, weakness and fatigue, low blood counts leading to increased risk of infection or bleeding problems. It might also cause nerve damage resulting in numbness or tingling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I don't have heart rhythm problems needing medication.

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I can have blood drawn without any issues.

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I do not have severe heart failure symptoms.

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My heart condition is stable and under control.

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I have not had repeated blood clot events.

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My calcium levels are stable and within normal range.

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I do not have any active stomach or intestine diseases that affect how my body processes food.

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My advanced cancer may improve with a specific treatment.

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My blood pressure is stable and under control.

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I do not have any uncontrolled health conditions like diabetes.

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I do not need constant oxygen therapy and my oxygen levels are stable without assistance.

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I have never had repeated lung infections due to inhaling food or liquid.

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I am between 18 and 75 years old.

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My liver function tests are within the required range.

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My kidney function, measured by creatinine, is within normal limits.

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My digestive system is functioning properly.

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I do not have ongoing severe diarrhea or untreated stomach ulcers.

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I do not have severe numbness or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,643 Total Patients Enrolled

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,492 Total Patients Enrolled

Daniel M. Sullivan, MDStudy ChairH. Lee Moffitt Cancer Center and Research Institute

2 Previous Clinical Trials

Media Library

Vinorelbine (Vinca Alkaloids) Clinical Trial Eligibility Overview. Trial Name: NCT00006088 — Phase 1

Solid Tumors Clinical Trial 2023: Vinorelbine Highlights & Side Effects. Trial Name: NCT00006088 — Phase 1

Vinorelbine (Vinca Alkaloids) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00006088 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study available to participants at the present time?

"According to clinicaltrials.gov, this research is not presently enrolling participants; the trial was initially posted on June 1st 2000 and last updated nineteen years ago in September 2013. Despite this study's closure for recruitment purposes, there are over two thousand trials actively searching for new patients today."

Answered by AI

Is participation in this research limited to those over a certain age?

"This trial requires potential participants to be aged between 18 and 75. Separately, 302 studies for minors younger than 18 years old are available; similarly 2223 studies cater to seniors over the age of 65."

Answered by AI

Has this remedy been legitimized by the FDA?

"This is a Phase 1 clinical trial, so the safety rating received by our team at Power was rather low, scoring only a 1. This suggests that there is limited evidence supporting both efficacy and safety of this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vinorelbine in Treating Patients With Metastatic or Advanced Solid Tumors

2000. "Vinorelbine in Treating Patients With Metastatic or Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00006088.

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