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

  • STATUS
    Recruiting
  • participants needed
    18
  • sponsor
    Tom Badgett
Updated on 8 November 2020

Summary

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.

Details
Condition Solid Tumor
Treatment Irinotecan + Eribulin
Clinical Study IdentifierNCT02318589
SponsorTom Badgett
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

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. pegfilgrastim)
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 eligible
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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