Phase I of Eribulin and Oral Irinotecan for Relapsed or Refractory Solid Tumors

Therapuetic Areas:Oncology
Age Range:15 - 39
Start Date:August 2015
End Date:June 30, 2020
Contact:Tom Badgett, MD, PhD

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A Phase I Study of Eribulin in Combination With Oral Irinotecan for Adolescent and Young Adult Patients With Relapsed or Refractory Solid Tumors

This Phase I trial will establish the recommended phase II dose of eribulin in combination
with fixed doses of oral irinotecan in adolescents and young adults with relapsed or
refractory solid tumors. Eribulin will be administered intravenously on days 1 and 8 of a
21-day cycle, while irinotecan will be administered orally on days 1-5. Patients will be
assigned an eribulin dose level at the time of enrollment using a 3 + 3 Phase I design.

Inclusion Criteria:

- Patients must be >15 and < 40 years of age at the time of study entry

- Patients must have had a histologically confirmed solid tumor malignancy at either
original diagnosis or relapse for which no curative therapy exists. Patients with
primary brain tumors, or those with brain metastases at time of potential enrollment,
are excluded

- Patients must have either measurable or evaluable disease

- Performance Level: ECOG performance status ≤ 2 (Karnofsky ≥60%, see Appendix A). Note:
Patients who are unable to walk because of paralysis, but who are up in a wheelchair,
will be considered ambulatory for the purposes of assessing the performance score

- Prior Therapy: No limit is placed on the number of prior therapies. Prior treatment
with irinotecan or eribulin is allowed, although patients must not have received
co-administration of eribulin and irinotecan and must not have had disease progression
while receiving either eribulin or irinotecan. Patients must have fully recovered from
the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
prior to entering this study

- Myelosuppressive chemotherapy: Must not have received within three weeks of start
date of this protocol chemotherapy; six weeks is required after administration of
nitrosourea agents

- Hematopoietic growth factors: At least 7 days since the completion of therapy
with a growth factor or at least 14 days for a long-acting growth factor (e.g.

- Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy
with a biologic agent. For agents that have known adverse events occurring beyond
7 days after administration, this period must be extended beyond the time during
which adverse events are known to occur. The duration of this interval must be
discussed with the PI of the study

- Immunotherapy: At least 6 weeks since the completion of any type of immunotherapy
(e.g. tumor vaccines)

- Monoclonal antibodies: At least 3 half-lives must have elapsed since prior
therapy that included a monoclonal antibody

- Radiotherapy: ≥ 2 weeks for local palliative XRT (small port); ≥ 6 months must
have elapsed if prior TBI, craniospinal XRT; ≥ 3 months must have elapsed if ≥
50% radiation of pelvis; ≥ 6 weeks must have elapsed if therapeutic doses of MIBG
or other substantial BM irradiation was given

- Stem Cell Transplant or Rescue without TBI: No evidence of active graft vs. host
disease and ≥ 2 months must have elapsed

- Organ Function Requirements: Patients must have normal organ and marrow function as
defined below

- Absolute neutrophil count ≥ 1,000/mcL

- Platelets ≥ 100,000/mcL (transfusion independent, defined as not receiving
platelet transfusions within a 7-day period prior to enrollment)

- Hemoglobin ≥ 8.0 g/dl (may receive RBC transfusions)

- Total bilirubin ≤ 1.5 × institutional upper limit of normal for age

- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal

- Albumin ≥ 2 g/dl

- Creatinine within normal institutional limits for age OR

- creatinine clearance ≥ 70 mL/min/1.73 m2 for patients with creatinine levels
above institutional normal

- Contraception: Because chemotherapeutic agents may be teratogenic, males and females
of child-bearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the duration
of study participation and for 4 months after the last dose of study chemotherapy

- All patients > 18 years must sign a written informed consent. Patients < 18 years old
must sign an assent document, and the parent or legal guardian must sign the written
informed consent

Exclusion Criteria:

- Pregnancy or Breast-Feeding: Patients who are pregnant or breast-feeding are not
eligible for this study due to the potential for fetal or teratogenic toxicities.
Negative pregnancy tests must be obtained in female patients who are post-menarchal

- Concomitant Medications:

- Growth factor(s): Growth factors that support platelet or white cell number or
function must not have been administered within the 7 days prior to enrollment
(14 days if pegfilgrastim)

- Corticosteroids: Patients receiving corticosteroids who have not been on a stable
or decreasing dose of corticosteroid for the 7 days prior to enrollment are not

- Investigational Drugs: Patients who are currently receiving another
investigational drug are not eligible

- Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents
are not eligible

- Enzyme-inducing anticonvulsants or other medications: Patients who are currently
receiving the enzyme inducing anticonvulsants: phenytoin, phenobarbital,
carbamazepine, oxcarbazepine are not eligible. Patients who are currently taking
rifampin, voriconazole, itraconazole, ketoconazole, aprepitant, or St. John's
Wort are not eligible

- Anticoagulants: Use of warfarin is not allowed while on study. Patients already
on warfarin should use alternative anticoagulants while on this study. Warfarin
must not have been administered within 7 days of starting protocol therapy

- Infection: Patients who have an uncontrolled infection, or who are currently receiving
treatment for C difficile infection

- Patients with a history of allergic reactions attributed to eribulin or irinotecan

- Patients with documented allergy to cephalosporins

- Patients with CNS tumors or known brain metastases

- Patients with known metastatic tumor in the bone marrow

- Patients who in the opinion of the investigator may not be able to comply with the
safety monitoring requirements of the study

- Uncontrolled intercurrent illness that would limit compliance with study requirements

- HIV-positive patients on combination antiretroviral therapy are ineligible because of
the potential for pharmacokinetic interactions with eribulin and irinotecan. In
addition, these patients are at increased risk of lethal infections when treated with
marrow-suppressive therapy
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Lexington, KY
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