Study of Erlotinib in Combination With Bortezomib

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00895687
First received: May 6, 2009
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

The goal of this clinical research study is to find the highest tolerable dose of Tarceva (erlotinib hydrochloride) that can safely be given in combination with Velcade (bortezomib). The safety of this drug combination will also be studied.


Condition Intervention Phase
Advanced Cancer
Drug: Erlotinib Hydrochloride
Drug: Bortezomib
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose-Escalation Study of Erlotinib in Combination With Bortezomib in Subjects With Advanced Cancer. Companion Study to Umbrella Protocol 2007-0638.

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Tumor Response [ Time Frame: Evaluation of response after two 21-day cycles of treatment ] [ Designated as safety issue: Yes ]
  • Maximum Tolerated Dose (MTD) [ Time Frame: Continuous assessment of safety throughout entire study period and determination of dose-limiting toxicities during and at the end of 21 Day Cycle. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: April 2009
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib + Bortezomib
Up to 4 dose levels of study drug combination tested with 3-6 participants enrolled at each dose level. Erlotinib beginning dose of 150 mg taken by mouth daily for 21-day cycle. Bortezomib beginning dose of 1. mg/m^2 by vein over about 1-5 minutes on Days 1, 4, 8, and 11 of each 21-day cycle.
Drug: Erlotinib Hydrochloride
Beginning dose of 150 mg taken by mouth daily for 21-day cycle.
Other Names:
  • Erlotinib
  • Tarceva
Drug: Bortezomib
Beginning dose of 1. mg/m^2 by vein over about 1-5 minutes on Days 1, 4, 8, and 11 of each 21-day cycle.
Other Names:
  • Velcade
  • LDP-341
  • MLN341
  • PS-341

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have had no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
  2. Measurable or non-measurable disease.
  3. Patients must be >/= 6 wks beyond treatment with a nitrosourea or mitomycin-C, >/= 4 wks beyond other chemotherapy or XRT, and must have recovered to </= Grade 1 toxicity for any treatment-limiting toxicity resulting from prior therapy. (Exception: patients may have received palliative low dose XRT one week before treatment provided it is not given to the only targeted lesions).
  4. (continued from above) Also, patients who have received non-chemotherapeutic biological agents will need to wait at least 5 half-lives or 4 wks, whichever is shorter, from the last day of treatment.
  5. ECOG performance status </= 2 (Karnofsky >/= 60%)
  6. Patients must have normal organ and marrow function defined as: absolute neutrophil count >/=1,000/mL; platelets >/=50,000/mL; creatinine </= 2 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 3 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT(SGPT) </= 5 X ULN.
  7. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
  8. Ability to understand and the willingness to sign a written informed consent document
  9. For the MTD expansion cohort, patients will be eligible if they meet one of the following criteria: (I) Have an EGFR-sensitive mutation and have been previously treated with EGFR inhibitor therapy but have subsequently developed resistance, OR (II) Have an EGFR-resistant mutation, OR (III) Do not have an EGFR mutation, but have benefited from EGFR inhibitor therapy (including either >/=4 months of stable disease [SD] OR a >/= partial response [PR]).

Exclusion Criteria:

  1. Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection; altered mental status or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results.
  2. Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg on medication).
  3. Patients with clinically significant cardiovascular disease: history of CVA within 6 months, myocardial infarction or unstable angina within 6 months, or unstable angina pectoris.
  4. Patients with colorectal carcinoma with tumors that demonstrate a KRAS mutation.
  5. Pregnant or lactating women.
  6. Patients with a history of bone marrow transplant within the previous two years.
  7. Patients with a known hypersensitivity to any of the components of the drug products.
  8. Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of oral drugs.
  9. Patients with major surgery within 30 days prior to entering the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895687

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jennifer J. Wheler, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00895687     History of Changes
Other Study ID Numbers: 2008-0554, NCI-2012-01631
Study First Received: May 6, 2009
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Metastatic Cancer
Bortezomib
Velcade
Erlotinib
Erlotinib Hydrochloride
Tarceva
EGFR
EGFR mutations

Additional relevant MeSH terms:
Neoplasms
Bortezomib
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014