Clinical trial 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 chemotherapy drug being studied for use in patients with 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
- The study compares algorithm‑guided dosing to usual care to see if it lowers unplanned treatment delays during chemotherapy.
- Who it's for
- Adults with cancers of the gastrointestinal system such as colon, stomach, esophagus, rectum, or pancreas.
- What's involved
- Participants receive chemotherapy, with doses either guided by the PAGODA algorithm or by standard practice, and attend regular clinic visits and tests.
- Time commitment
- The study lasts for the duration of the chemotherapy course, with visits at each treatment cycle.
- 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.
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).
- Concomitant monoclonal antibodies are permitted during FOLFOX-based chemotherapy (e.g. anti-VEGF, anti-EGFRs, anti-PD1/PDL1, and anti-HER2)
- Patients receiving concomitant therapy with irinotecan or docetaxel are not eligible
- 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
- Patients with 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.
- 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
- Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency are ineligible
- 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 is enrolling
- 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 Cruz, 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
+ 270 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, but 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?
This study is enrolling now at 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 284 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.