Phase 2 N=29 Treatment

Erlotinib Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome · Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 · Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11 · Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 · Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A

Bottom Line

View on ClinicalTrials.gov: NCT01664897 ↗

Enrolled (actual)

Serious AEs

79.3%

Results posted

Jan 2020

Primary outcome: Primary: Participants With a Response — 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Erlotinib Hydrochloride (Drug); Laboratory Biomarker Analysis (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants With a Response	3	—
PRIMARY Incidence of Clinically Significant, Non-hematologic Grade 3 or 4 Toxicities at Least Possibly Related to Erlotinib Hydrochloride	10; 10; 8; 7	—
PRIMARY Overall Survival	14	—
PRIMARY Event-free Survival	5	—
SECONDARY Biomarker Expressions	—	—

Summary

This pilot phase II trial studies how well erlotinib hydrochloride works in treating patients with relapsed or refractory acute myeloid leukemia. Erlotinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

Inclusion Criteria

Patients with AML who have either been refractory to prior therapy or have relapsed after prior therapy; patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) who received therapy with a hypomethylating agent and progress to AML are eligible if they have received any therapy for MDS and failed (i.e., lack or loss of response) regardless of whether they have received therapy for AML or not; the World Health Organization (WHO) classification will be used for AML
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Total bilirubin =< 2 x upper limit of normal (ULN)
Alanine aminotransferase (ALT) =< 2.5 x ULN
Creatinine =< 2 x ULN
Patients must provide written informed consent
Patients must have been off chemotherapy for 2 weeks prior to entering this study, unless there is evidence of rapidly progressive disease, and must have recovered from the clinically significant toxic effects of that therapy to at least grade 1; use of hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy
Patients-both males and females-with reproductive potential (i.e., menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study; women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to initiation of study

Exclusion Criteria

Patients with known allergy or hypersensitivity to erlotinib
Patients with any other known disease (except carcinoma in-situ) concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure New York Heart Association [NYHA] class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study
Patients unwilling or unable to comply with the protocol
Significant gastrointestinal disorders that may interfere with absorption of erlotinib
Patients who can receive a stem cell transplant within 4 weeks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01664897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.