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NCT04205968 · ClinicalTrials.gov registry record · Phase 2
Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers
A Phase 2 study of Metastatic Small Intestinal Adenocarcinoma and Stage IV Small Intestinal Adenocarcinoma AJCC v8, sponsored by SWOG Cancer Research Network.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
- 20
- Study locations
NCT04205968: Recruiting Phase 2 study of Metastatic Small Intestinal Adenocarcinoma and Stage IV Small Intestinal Adenocarcinoma AJCC v8, sponsored by SWOG Cancer Research Network.
NCT04205968 is a Phase 2 study of Metastatic Small Intestinal Adenocarcinoma and Stage IV Small Intestinal Adenocarcinoma AJCC v8 that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 94 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04205968, a Phase 2 study of Metastatic Small Intestinal Adenocarcinoma and Stage IV Small Intestinal Adenocarcinoma AJCC v8, is actively recruiting participants, sponsored by SWOG Cancer Research Network.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment (refractory). Ramucirumab is a monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2. This may restrain new blood vessel formation therefore reducing nutrient supply to tumor which may interfere with tumor cell growth and expansion. Drugs used in chemotherapy, such as paclitaxel, leucovorin calcium, fluorouracil, and irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Ramucirumab plus paclitaxel or FOLFIRI, may be helpful in treating advanced or refractory small bowel cancers and may help patients live longer.
Primary Outcome
PFS will be assessed in all eligible and evaluable (received at least one dose of protocol therapy) patients using the Kaplan-Meier method, with statistical differences in event rates between treatment arms assessed via stratified Cox regression model.
Conditions Studied
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Irinotecan
- DRUG Irinotecan Hydrochloride
- DRUG Leucovorin Calcium
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
California
- Kaiser Permanente-Anaheim - Anaheim
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- CARTI Cancer Center - Little Rock
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 2 |
What NCT04205968 shows while recruiting
NCT04205968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 5 conditions, with Metastatic Small Intestinal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.
NCT04205968 names 20 study sites across 4 states, led by Alaska, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04205968 about?
NCT04205968 is a clinical study titled "Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers". This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to tr...
What is the current status of trial NCT04205968?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2020-06-01. Estimated completion is 2027-08-01.
What conditions does trial NCT04205968 study?
This clinical trial studies the following conditions: Metastatic Small Intestinal Adenocarcinoma, Stage IV Small Intestinal Adenocarcinoma AJCC v8, Stage III Small Intestinal Adenocarcinoma AJCC v8, Stage IIIA Small Intestinal Adenocarcinoma AJCC v8, Stage IIIB Small Intestinal Adenocarcinoma AJCC v8.
What interventions are being tested in trial NCT04205968?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Irinotecan (DRUG), Irinotecan Hydrochloride (DRUG), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT04205968?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04205968 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04205968's enrollment target sits among peer trials
94 764th of 2000 higher than 1,236 of 2,000 other Phase 2 trials
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