Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers

Conditions

• Metastatic Small Intestinal Adenocarcinoma
• Stage III Small Intestinal Adenocarcinoma AJCC v8
• Stage IIIA Small Intestinal Adenocarcinoma AJCC v8
• Stage IIIB Small Intestinal Adenocarcinoma AJCC v8
• Stage IV Small Intestinal Adenocarcinoma AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fluorouracil — DRUG
  Given IV bolus or IV
• Irinotecan — DRUG
  Given IV
• Irinotecan Hydrochloride — DRUG
  Given IV
• Leucovorin — DRUG
  Given IV
• Leucovorin Calcium — DRUG
  Given IV
• Paclitaxel — DRUG
  Given IV
• Ramucirumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Jun 1, 2020

Status verified

Nov 2025

Primary completion

Aug 1, 2026

Completion

Aug 1, 2027

Study Design

Enrollment

94 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (ramucirumab, paclitaxel)
  Patients receive ramucirumab IV over 30-60 minutes on days 1 and 15, and paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (irinotecan, leucovorin, fluorouracil)
  Patients receive irinotecan IV over 90 minutes on days 1 and 15, leucovorin IV over 2 hours on days 1 and 15, and fluorouracil IV bolus on days 1 and 15. Patients also receive fluorouracil IV over 46-48 hours on days 1-3 and 15-17. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years ]

Central Contacts

• Christy Klepetko
  210/614-8808
  [email protected]
• Dana Sparks
  210/614-8808
  [email protected]

Locations (536)

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