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Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers

ConditionsMetastatic Small Intestinal AdenocarcinomaStage III Small Intestinal Adenocarcinoma AJCC v8Stage IIIA Small Intestinal Adenocarcinoma AJCC v8Stage IIIB Small Intestinal Adenocarcinoma AJCC v8Stage IV Small Intestinal Adenocarcinoma AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSWOG Cancer Research Network

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have histologically or cytologically confirmed small bowel adenocarcinoma. Ampullary adenocarcinomas are not eligible. Patients must have metastatic disease or locally advanced unresectable disease

Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to registration. Patients must be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to registration

Patients must have measurable or non-measurable disease. All scans needed for assessment of measurable disease must be performed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form

Patients must have progressed on prior therapy with a fluoropyrimidine and/or oxaliplatin, given either for metastatic/locally advanced disease or as adjuvant therapy completed within the previous 12 months

Disqualifiers

Patients must not have received prior treatment with irinotecan, taxane, or ramucirumab for small bowel adenocarcinoma

Patients must not have had major surgery within 28 days prior to registration, or minor surgery within 7 days prior to registration, and must not be planned for elective major surgery to be performed during protocol treatment

Patients must not be currently enrolled in or have discontinued within the last 28 days a clinical trial involving an investigational product or non-approved use of a drug, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Patients participating in surveys or observational studies are eligible to participate in this study

Patients must not be receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Vaccine

    Given IV

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Arm I (ramucirumab, paclitaxel)Experimental treatment 2 interventions
Group B: Arm II (irinotecan, leucovorin, fluorouracil)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

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.

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

Secondary outcomes

1

Overall survival (OS)

Probabilities of OS will be estimated using the method of Kaplan-Meier, with statistical differences in event rates between treatment arms assessed via stratified Cox regression model.

Time frame
From date of registration to date of death due to any cause, assessed up to 3 years
2

Overall response rate

Will be assessed by Response Evaluation Criteria in Solid Tumors 1.1. Will be compared across treatment arms via chi-square tests.

Time frame
Up to 3 years after registration
3

Incidence of adverse events

Will be compared across treatment arms via chi-square tests.

Time frame
Up to 3 years after registration

Other outcomes

1

CEA level

CEA levels will be measured at the beginning of the first cycle and every 8 weeks during the study. Maximum decrease in CEA levels from treatment onset and time to maximum decrease in CEA will be summarized in descriptive analyses. Decrease in CEA levels will be defined as high (\>= 50% change) versus low (\< 50% change).

Time frame
Up to 3 years after registration

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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