Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00996515
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : May 1, 2013
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

Tracking Information
First Submitted Date  ICMJE October 14, 2009
First Posted Date  ICMJE October 16, 2009
Last Update Posted Date May 1, 2013
Study Start Date  ICMJE June 2008
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
Quality and quantity of adverse events due to administration of erlotinib + 5-azacytidine, as therapy for the treatment of advanced or metastatic cancer. [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00996515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies
Official Title  ICMJE A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies
Brief Summary

PRIMARY OBJECTIVES:

I. To document the toxicities, and reversibility of toxicities, of this regimen of 5-azacytidine (azacitidine) and erlotinib (erlotinib hydrochloride).

SECONDARY OBJECTIVES:

I. To determine any potential anti-tumor effects, as determined by the objective tumor response (complete and partial responses), clinical benefit (complete and partial responses, and clinical benefit), the time to tumor response, the time to tumor progression, and the overall survival.

Detailed Description

OUTLINE: This is a dose-escalation study.

Patients receive azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) on days 1 and 15, days 1-2 and 15-16, days 1-3 and 15-17, or days 1-4 and 15-18. Patients also receive erlotinib hydrochloride orally (PO) daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 28 days and then every 3 months for 5 years.

Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor Malignancies
Intervention  ICMJE
  • Drug: 5-azacytidine, erlotinib
    Erlotinib 150 mg PO daily, days 1-8, and 15-22 5-Azacytidine 75 mg/m2/day, IV days 1 and 15
    Other Names:
    • Erlotinib :- Tarceva™ (OSI-774)
    • Vidaza (5-azacytidine)
  • Drug: Erlotinib PO and Vidaza IV
    Patients enrolled to 1 of 5 cohorts, with varying drug doses and dose scheduling.
Study Arms
  • Experimental: Cohort 5
    Erlotinib 150mg/day PO Day 1-28 and Vidaza 100mg/m2/day SQ Day 1-4 and 15-18
    Interventions:
    • Drug: 5-azacytidine, erlotinib
    • Drug: Erlotinib PO and Vidaza IV
  • Experimental: Cohort 4
    Erlotinib 200 mg/day PO Day 1-28 and Vidaza 75 mg/m2/day SQ 1-4 and 15-18
    Interventions:
    • Drug: 5-azacytidine, erlotinib
    • Drug: Erlotinib PO and Vidaza IV
  • Experimental: Cohort 3
    Erlotinib 150 mg/day PO Day 1-28 and Vidaza 75 mg/m2/day IV Day 1-3 and 15-17
    Interventions:
    • Drug: 5-azacytidine, erlotinib
    • Drug: Erlotinib PO and Vidaza IV
  • Experimental: Cohort 2
    Erlotinib 150 mg/day PO Day 1-28 and Vidaza 75 mg/m2/day IV Day 1-2 and 15-16
    Interventions:
    • Drug: 5-azacytidine, erlotinib
    • Drug: Erlotinib PO and Vidaza IV
  • Experimental: Cohort 1
    Erlotinib 150 mg/day PO Day 1-28 and Vidaza 75 mg/m2/day IV Day 1 and 15
    Interventions:
    • Drug: 5-azacytidine, erlotinib
    • Drug: Erlotinib PO and Vidaza IV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date September 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must fulfill all of the following criteria to be eligible for study entry:
  • Those who will be eligible will be all patients with non-hematologic neoplasms (lymphomas, leukemias, myeloma, myelodysplasia, or myeloproliferative syndromes) who have disease which has been previously treated and/or for which there is no acceptable standard treatment regimen available, and cannot be treated definitively with either surgery or radiotherapy. All will be appropriate candidates for treatment, and are not candidates for treatment with protocols of higher priority. All patients should have an ECOG/Zubrod/SWOG performance status of <2 at the time of the initiation of therapy, adequate end-organ function, no severe comorbid disease, and ability to provide informed consent.

Other Eligibility Criteria:

  • Signed Informed Consent
  • ECOG/Zubrod/SWOG Performance Status <2 (Karnofsky Performance Status > 70%)
  • Life expectancy > 8 weeks
  • Male or female' age >18 years
  • Patients of childbearing potential must be using an effective means of contraception.
  • Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
  • Histologic diagnosis of a solid tumor malignancy that is advanced and cannot be treated adequately by radiotherapy or surgery; or metastatic disease
  • Baseline laboratory values (bone marrow, renal, hepatic):

    • Adequate bone marrow function:
    • Absolute neutrophil count >1000/µL
    • Platelet count >100'000/µL
    • Renal function:
  • Serum creatinine < 1.5 x ULN

    • Hepatic function:
  • Bilirubin <1.5x normal

    • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels <=2 x ULN
    • Serum calcium < 12 mg/dl

Exclusion Criteria:

Patients meeting any of the following criteria are ineligible for study entry:

  • Pregnant or lactating females
  • Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0
  • Uncontrolled' clinically significant dysrhythmia
  • Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
  • Uncontrolled metastatic disease of the central nervous system
  • Sensitivity to erlotinib, 5-azacytidine or mannitol
  • Advanced hepatic tumors
  • Radiotherapy within the 2 weeks before Cycle 1' Day 1
  • Surgery within the 2 weeks before Cycle 1' Day 1
  • Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00996515
Other Study ID Numbers  ICMJE INST 0710C
NCI-2011-02646 ( Registry Identifier: NCI CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party New Mexico Cancer Care Alliance
Study Sponsor  ICMJE New Mexico Cancer Care Alliance
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie E Bauman, M.D. University of New Mexico Cancer Center
PRS Account New Mexico Cancer Care Alliance
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP