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Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Women and Infants Hospital of Rhode Island
Information provided by (Responsible Party):
Neil S. Horowitz, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00476476
First received: May 18, 2007
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

In this research study we are looking to see how vulvar cancer responds to a short course (4-6 weeks) of erlotinib. Another goal of this study is to learn more about the proteins and genes present in vulvar cancer and how they may affect response to erlotinib. Erlotinib treats cancer by preventing cancer cells from growing and multiplying. It does this by blocking certain proteins that are on the surface of some types of cancer cells. Laboratory tests show that vulvar cancer cells have high levels of these proteins.


Condition Intervention Phase
Squamous Cell Carcinoma
Drug: Erlotinib
Phase 2

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 II Trial of Tarceva (Erlotinib) in Women With Squamous Cell Carcinoma of the Vulvar

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the safety and tolerability of oral erlotinib in women with locally advanced primary or recurrent vulvar squamous cell cancer [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • to determine the clinical efficacy of a 4-6 week course of erlotinib in reducing the size of vulvar squamous cell cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate apoptosis and assess the Ki67, phospho-EGFR, EGFR mutation and EGFR amplification status of the vulvar cancer prior to and after therapy and correlate observed changes with response to therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • to evaluate the impact of medical treatment and subsequent surgery for vulvar cancer. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: December 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib Drug: Erlotinib
Orally every day for about 4-6 weeks
Other Name: Tarceva

Detailed Description:
  • Participants will take erlotinib everyday for about four to six weeks (28-42 days). Erlotinib is a pill that is taken orally. Participants will receive a drug diary to record each dose of erlotinib they take. While participants are taking erlotinib, they will be contacted by telephone once a week.
  • Participants will receive additional treatment that is standard for their stage of cancer when they stop study treatment. If they are undergoing surgery to remove the cancer the surgery will be performed on the day of their last dose of erlotinib. A piece of tumor tissue will be saved for research-related tests. If they are receiving chemotherapy and/or radiation therapy to treat the cancer, a biopsy will be done before they begin chemotherapy or radiation. A piece of the biopsy sample will be used for research-related tests.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed measurable squamous cell carcinoma of the vulvar with an assessable lesion on the vulva or measurable metastatic disease. Tumors may be primary or recurrent. Patients must have plans for surgery or definitive treatment with chemotherapy +/-radiation unless they have measurable metastatic disease.
  • 18 years of age or older
  • No concurrent chemotherapy or radiotherapy
  • NO previous chemotherapy or radiotherapy within the preceding 1 month
  • ECOG performance status of 0-1

Exclusion Criteria:

  • Known hypersensitivity reaction to erlotinib
  • Other coexisting malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma
  • Treatment with a non-FDA approved or investigational drug within 30 days
  • Persistent toxicities (grade 2 or above) from previous treatment, expect alopecia or lymphedema
  • Serum creatinine level greater than CTC grade 2
  • Pregnancy or breast feeding
  • Severe or uncontrolled systemic disease
  • Significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate
  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: NCT00476476

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Dana-Farber Cancer Institute
Genentech, Inc.
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Neil S. Horowitz, MD Dana-Farber Cancer Institute/Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Neil S. Horowitz, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00476476     History of Changes
Other Study ID Numbers: 06-174
Study First Received: May 18, 2007
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Tarceva
erlotinib
squamous cell carcinoma of the vulvar

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014