Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Genentech
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: December 12, 2012
Last verified: December 2012
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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) |
Intervention Details:
Detailed Description:
-
Drug: Erlotinib
Orally every day for about 4-6 weeks
Other Name: Tarceva
- 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
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 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02214 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| 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
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: | December 12, 2012 |
| 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, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013