SWOG clinical trial number
S1922

Randomized Phase II Study of Ramucirumab and Paclitaxel versus FOLFIRI in Refractory Small Bowel Adenocarcinoma

Open
Phase
II
Accrual
0%
Abbreviated Title
Randomized Phase II Study of Ramucirumab and Paclitaxel versus FOLFIRI in Refractory<br />Small Bowel Adenocarcinoma
Status Notes
The study referenced above is open for participation effective Monday, December 16, 2019 at 2:00 p.m. Eastern.
Activated
12/16/2019
Participants
ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS LISTED ON TITLE PAGE

Research committees

Gastrointestinal Cancer

Treatment

Irinotecan Leucovorin + 5-FU Ramucirumab Paclitaxel

Eligibility Criteria Expand/Collapse

Disease Related Criteria

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

b. Brain mets 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 w/o corticosteroid treatment for at least 7 days prior to registration.

c. Pts 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.

Prior/Concurrent Therapy Criteria
Patients must:
a. 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.

b. not have received prior treatment with irinotecan, taxane, or ramucirumab for small bowel adenocarcinoma.

c. have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to registration and all toxicity must be resolved to Grade 1 (with the exception of Grade 2 neuropathy) prior to registration. In CTCAE version 5.0 Grade 2 sensory neuropathy is defined as “moderate symptoms; limiting instrumental activities of daily living (ADLs)”

d. 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.

e. 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.

f. not be receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents.

Clinical/Laboratory Criteria
Patients must:

a. have a complete medical history and physical exam within 28 days prior to registration.

b. be at least 18 years

c. have a Zubrod Performance Status of 0 or 1

d. have adequate bone marrow function as evidenced by all of the following: ANC equal or greater than 1,500/mcL and platelets equal or greater than 100,000/mcL. These results must be obtained within 28 days prior to registration.

e. have adequate hepatic function as evidenced by a total bilirubin less than or equal 1.5 x institutional limit normal (IULN), and SGOT (AST) and SGPT (ALT) less than or equal 3.0 x IULN (or 5.0 x IULN if liver metastases are present). These results must be obtained within 28 days prior to registration.

f. not have a known bleeding diathesis

g. have adequate renal function as evidenced by ONE of the following: serum creatinine less than or equal 1.5 x IULN OR calculated creatinine clearance greater to or equal 40 mL/min. This serum creatinine result must have been obtained within 28 days prior to registration.

h. have urinary protein less than or equal 1+ on dipstick or routine urinalysis (UA) within 28 days prior to registration. If dipstick or routine analysis is greater than or equal 2+, a 24 - hour urine collections for protein must demonstrate less than 1000 mg of protein in 24 hours.

i. not have uncontrolled or poorly-controlled hypertension (greater than 160 mmHg systolic or greater than 100 mm HG diastolic for more than 4 weeks) despite standard medical management.

j. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

k. Patient tumors must not have known deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H).

l. not be pregnant or nursing and must have had a negative pregnancy test within 4 weeks of starting treatment. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.

m. not have an active infection requiring systemic therapy.

n. not have liver dysfunctions manifested by either (1) Child-Pugh B (or worse) or (2) cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.

o. not have known dihydropyrimidine dehydrogenase deficiency.

p. not have a history of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered “significant”) during the 90 days prior to registration.

q. not have experienced any arterial thrombotic event (including but not limited to myocardial infarction, unstable angina, stable angina markedly limiting ordinary physical activity, cerebrovascular accident, or transient ischemic attack) within 120 days prior to registration.

r. not have a prior history of GI perforation/fistula or other risk factors for perforation within 120 days prior to registration.

s. not have experienced any Grade 3-4 GI bleeding within 90 days prior to registration.

t. not have experienced any serious or non-healing wound, ulcer, or bone fracture within 28 days prior to registration.

Specimen Submission Criteria

a. Patients must be offered the opportunity to participate in specimen banking as outlined in Section 15.1.

Regulatory Criteria

a. Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

b. As a part of the OPEN registration process (see Section 13.3 for OPEN access instructions) the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

Reports & Approvals

Trial Locations

Other Clinical Trials

SWOG Clinical Trial Number
S1922

Randomized Phase II Study of Ramucirumab and Paclitaxel versus FOLFIRI in Refractory Small Bowel Adenocarcinoma

Research Committee(s)
Gastrointestinal Cancer
Activated
12/16/2019
Accrual
0%
Open
Phase
II
SWOG Clinical Trial Number
S1815
SWOG Clinical Trial Number
S1613