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Anti-metabolites

Nab-paclitaxel 150 mg/m^2 for Gastroesophageal Junction Adenocarcinoma

Phase 2
Waitlist Available
Led By Al B. Benson, MD
Research Sponsored by Al B. Benson, III, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from c1d1 until death or up to a maximum of 52 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combination to see if it is effective and safe for patients with stomach or gastroesophageal junction cancer.

Eligible Conditions
  • Gastroesophageal Junction Adenocarcinoma
  • Stomach Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from c1d1 until death or up to a maximum of 52 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from c1d1 until death or up to a maximum of 52 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate
Secondary outcome measures
Disease Control Rate (DCR)
Number of Subjects Achieve Best Overall Response of CR, PR, SD and PD
Overall Survival (OS)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment4 Interventions
All patients in Stage I (N=12) and Stage II (N=25) will receive FOLFOX-A on days 1 and 15 of each cycle (1 cycle = 28 days). Nab-paclitaxel will be given at a dose of 150 mg/m^2 IV over 30 minutes, followed by oxaliplatin IV 85 mg/m^2 and leucovorin IV 400 mg/m^2 over 2 hours, and 5-FU as a continuous IV infusion over Day 1 and Day 2 (for a total dose of 2400mg/m^2 over 46-48 hours.). Radiographic assessment will be performed at baseline and every other cycle (starting with Cycle 3) to evaluate response to treatment by RECIST Version 1.1 guidelines. Patients may continue to receive treatment until disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab-paclitaxel 150 mg/m^2
2017
Completed Phase 2
~40
Oxaliplatin 85 mg/m^2
2017
Completed Phase 3
~2080
5-FU 1200 mg/m^2 x 2 D
2017
Completed Phase 2
~40
Leucovorin 400 mg/m^2
2017
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Big Ten Cancer Research ConsortiumOTHER
10 Previous Clinical Trials
435 Total Patients Enrolled
Al B. Benson, III, MDLead Sponsor
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,197 Total Patients Enrolled

Media Library

5-FU (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03283761 — Phase 2
Gastroesophageal Junction Adenocarcinoma Research Study Groups: Treatment Arm
Gastroesophageal Junction Adenocarcinoma Clinical Trial 2023: 5-FU Highlights & Side Effects. Trial Name: NCT03283761 — Phase 2
5-FU (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03283761 — Phase 2

Frequently Asked Questions

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

In what geographical areas can participants access this clinical trial?

"This clinical trial requires patient recruitment and 8 locations are currently enrolling participants. These include the University of Iowa Hospitals & Clinics in Iowa City, Michigan State University in Lansing, as well as Northwestern Medicine Lake Forest Hospital in Lake Forest; among many others."

Answered by AI

Are there any vacant spots available to participants in this clinical research?

"Data on clinicaltrials.gov reveals that this medical trial is not actively recruiting patients at present time; the original posting was on September 21st 2017 and it was last updated October 17th 2022. Nevertheless, there are presently 2566 other studies which require participants to take part in them."

Answered by AI

How many participants have been recruited to join this research project?

"The trial is not presently recruiting; records on clinicaltrials.gov show that it was initially posted in September 2017 and last updated October 2022. There are currently 1277 medical studies searching for people with stomach malignant neoplasms, and another 1289 trials actively enrolling patients who wish to receive Nab-paclitaxel 150 mg/m^2."

Answered by AI

To what degree are patients exposed to potential hazards when taking Nab-paclitaxel 150 mg/m^2?

"Although the efficacy of Nab-paclitaxel 150 mg/m^2 has yet to be proven, there is ample evidence for its safety. Thus it received a score of 2 on our scale ranging from 1 to 3."

Answered by AI

In what types of cases is Nab-paclitaxel 150 mg/m^2 typically prescribed?

"Nab-paclitaxel 150 mg/m^2 is a viable treatment for issues such as neoplasm metastasis, macrocytic anemia, and bladder cancer."

Answered by AI

Have any prior studies investigated the efficacy of Nab-paclitaxel at a dosage of 150 mg/m^2?

"At present, 1289 research studies are currently testing the efficacy of Nab-paclitaxel 150 mg/m^2. Of these ongoing trials, 396 have reached Phase 3 status. Data shows that while most experiments involving this medication take place in Guangzhou, Guangdong there are a total of 67443 sites around the world running related clinical trials."

Answered by AI
~5 spots leftby Apr 2025