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New treatment option for Ampulla of Vater Carcinoma
Official title Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
ClinicalTrials.gov ID: NCT07283939
What this study is testing
What is Oxaliplatin?
Oxaliplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ampulla of vater carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study seeks to learn whether using the PAGODA algorithm to guide chemotherapy dosing will lower the chance of unplanned delays during chemotherapy for cancer in the gastrointestinal system compared to usual care.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- \ REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
- Histologic confirmation of invasive cancer that is confirmed or suspected to arise from the gastrointestinal (GI) tract
- Any stage for which FOLFOX-based chemotherapy is a clinically-indicated, standard-of-care treatment (adjuvant, neoadjuvant, or first-line...
- Eligible primary tumor sites include the esophagus, gastroesophageal junction, stomach, small intestine, ampulla of Vater, appendix, colon, rectum...
- Prior systemic therapy for GI cancer (other than cycle 1 of FOLFOX-based chemotherapy) is not allowed. Prior radiation-sensitizing chemotherapy is...
See the full eligibility criteria
- \ REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
- Histologic confirmation of invasive cancer that is confirmed or suspected to arise from the gastrointestinal (GI) tract
- Any stage for which FOLFOX-based chemotherapy is a clinically-indicated, standard-of-care treatment (adjuvant, neoadjuvant, or first-line chemotherapy)
- Eligible primary tumor sites include the esophagus, gastroesophageal junction, stomach, small intestine, ampulla of Vater, appendix, colon, rectum, and cancers of unknown primary with suspected GI origin
- Prior systemic therapy for GI cancer (other than cycle 1 of FOLFOX-based chemotherapy) is not allowed. Prior radiation-sensitizing chemotherapy is permitted
- The planned duration of FOLFOX-based chemotherapy must be at least four cycles (1 cycle = 14 days)
- Cycle 1, day 1 of FOLFOX-based chemotherapy must be completed 1 to 8 days prior to registration
- Cycle 1, day 1 of FOLFOX-based chemotherapy must include minimum ordered doses of oxaliplatin (≥ 65 mg/m\^2) and infusional 5-FU (2400 mg/m\^2/46 hours). Use of the 5-FU bolus is at the discretion of the treating...
- Patients who require primary prophylactic white blood cell growth factor with cycle 1 of FOLFOX chemotherapy due to high risk for fever and neutropenia are not eligible
- History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs, to fluorouracil, or to leucovorin, and the excipients in their formulations are not eligible
- Age ≥ 18 years
- ECOG performance status ≤ 2
- Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Total bilirubin ≤ 3 x upper limit of normal (ULN)
- AST (SGOT)/ALT (SGPT) ≤ 5 x upper limit of normal (ULN)
- Calc. creatinine clearance ≥ 30 mL/min
- Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 30...
- Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression
- Patients with known HIV infection are eligible if receiving effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration
- Patients with known chronic hepatitis B virus (HBV) infection are eligible if HBV DNA is undetectable when measured within 6 months prior to registration
- Patients with a known history of hepatitis C virus (HCV) infection are eligible if HCV RNA is undetectable when measured at least 12 weeks after completion of antiviral therapy
- Patients with known history or current symptoms of cardiac disease are eligible if the New York Heart Association Functional Classification is class I or II
- Patients with a known history of congenital long QT syndrome are ineligible
- Patients with known DPD deficiency are ineligible
- \ NON-PATIENT (ONCOLOGY PHYSICIAN OR ONCOLOGY ADVANCED PRACTICE PROVIDER ELIGIBILITY:
- The non-patient provider participant is a medical oncologist or oncology advanced practice provider with responsibility for signing and making necessary modifications to chemotherapy orders for a subject assigned to the...
- The non-patient participant must be proficient in the English language
- The non-patient participant must be age 21 years or older
The study team makes the final eligibility decision.
Where it's taking place
- Fairbanks, Alaska, United States
- Phoenix, Arizona, United States
- Fort Smith, Arkansas, United States
- Jonesboro, Arkansas, United States
- Little Rock, Arkansas, United States
- Arroyo Grande, California, United States
- Carmichael, California, United States
- Elk Grove, California, United States
- Merced, California, United States
- Rocklin, California, United States
- Sacramento, California, United States
- San Luis Obispo, California, United States
- Santa Maria, California, United States
- Stockton, California, United States
- Woodland, California, United States
- Colorado Springs, Colorado, United States
- Durango, Colorado, United States
- Lakewood, Colorado, United States
- Longmont, Colorado, United States
- Pueblo, Colorado, United States
+ 237 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fairbanks, Alaska, United States; Phoenix, Arizona, United States; Fort Smith, Arkansas, United States; Jonesboro, Arkansas, United States; Little Rock, Arkansas, United States; Arroyo Grande, California, United States and 251 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.