Clinical Trial of a Novel Dose Adjustment Algorithm for Preventing Cytopenia-Related Delays During FOLFOX Chemotherapy

Recruiting in Palo Alto (17 mi)

Overseen byGabriel A Brooks, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Dartmouth-Hitchcock Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

The study is testing an intervention of an investigator-developed chemotherapy dose adjustment algorithm. The primary objective of this study is to evaluate the effectiveness of the chemotherapy dose adjustment algorithm for reducing unplanned delays in patients receiving FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)-type chemotherapy, while maintaining acceptable chemotherapy dose-intensity.

Research Team

Gabriel A Brooks, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

Inclusion Criteria

The doctor recommends a chemotherapy treatment called mFOLFOX for at least six cycles, either with or without other drugs like bevacizumab or cetuximab. The purpose of the treatment can be to cure or to relieve symptoms.

Diagnosis of adenocarcinoma of the gastrointestinal tract (to include cancers of the colorectum, stomach, esophagus, appendix, and small bowel)

Completion of day 1 of cycle 1 of standard-of-care FOLFOX chemotherapy

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Exclusion Criteria

Prior receipt of systemic chemotherapy in the 12 months prior to day 1 of cycle 1 of mFOLFOX (other than radiation-sensitizing chemotherapy)

History of baseline neutropenia; defined as neutrophil count <1500 in the 30 days preceding planned day 1 of cycle 1 of mFOLFOX

History of baseline thrombocytopenia; defined as platelet count <100,000) in the 30 days preceding planned day 1 of cycle 1 of mFOLFOX

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