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Study of Erlotinib in the Treatment of Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (CSCC) of the Skin

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ClinicalTrials.gov Identifier: NCT01198028
Recruitment Status : Active, not recruiting
First Posted : September 9, 2010
Last Update Posted : September 27, 2017
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if erlotinib can help to control squamous cell carcinoma that has either come back or has spread. The safety of this drug will also be studied.

Condition or disease Intervention/treatment Phase
Skin Cancer Drug: Erlotinib Phase 2

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Detailed Description:

Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive erlotinib 1 time each day. Erlotinib should be taken with a cup (8 ounces) of water at about the same time each day.

Erlotinib should not be taken within 2 hours of taking short-acting antacid, such as Tums or Maalox.

If you are having have side effects caused by erlotinib, your dose may be lowered or you may be taken off study.

If you miss a dose and there is at least 12 hours before your next dose, you should take the missed dose. lf you vomit, you should not take another tablet until your next scheduled dose.

If necessary, erlotinib may be dissolved in water and given through a feeding tube.

You will be given a pill diary to record when you take erlotinib. You should bring your pill diary to each visit to be reviewed by the study staff. You should also return any unused tablets of erlotinib at each visit.

Study Visits:

On the day before you begin taking erlotinib and then every 4 weeks:

  • You will be asked about any side effects you may be having or drugs you may be taking.
  • You will have a physical exam, including measurement of your weight and vital signs.
  • You will be asked about your smoking status.
  • Your performance status will be recorded.
  • Blood (about 2-3 teaspoons) will be drawn for routine tests, including tests to check your blood clotting function.

Every 8 weeks:

  • You will have a CT or MRI scan and a chest X-ray to check the status of the disease.
  • If you have skin lesions, they will be measured and photographed.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur.

End-of-Treatment Visit:

About 30 days after your last dose of the study drug, the following tests and procedures will be performed:

  • You will be asked about any side effects you may be having and about any drugs you may be taking.
  • You will have a physical exam, including measurement of your vital signs.
  • Your performance status will be recorded.

Long-Term Follow-Up:

After your end-of-treatment visit, you will be contacted by telephone, in writing, by e-mail, or during clinic visits every 3 months to check the status of the disease and to ask about any treatment you may have received and any other side effects you may have had. If you cannot be found, your family members may be contacted for this information. This information may also be collected by checking your medical record.

This is an investigational study. Erlotinib is FDA approved and commercially available for the treatment of non-small cell lung cancer. Its use in this study is investigational.

Up to 33 patients will take part in this study. All will be enrolled at MD Anderson.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Erlotinib, an Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in the Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
Actual Study Start Date : March 2011
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Erlotinib
Erlotinib 150 mg by mouth for 8 weeks.
Drug: Erlotinib
150 mg by mouth for 8 weeks.
Other Names:
  • OSI-774
  • Tarceva
  • Erlotinib hydrochloride




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 8 weeks ]
    Evaluated after 8 weeks, patient considered a non-responder if tumor does not regress to complete or partial response as specified in RECIST v1.1 at that time point. ORR, based on overall response of each evaluable patient, is defined as percentage of patients who achieve an overall response of complete response or partial response in total number of evaluable patients.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have histologically or cytologically confirmed cutaneous squamous cell carcinoma (CSCC) that is not amenable to curative therapy. If the biopsy was collected outside of MDACC, the MDACC Pathology Department must assess and confirm the SCC diagnosis.
  2. Have measurable disease.
  3. Be at least 18 years of age.
  4. Have ECOG performance status 0-2.
  5. Must have ability to understand and the willingness to sign a written Informed Consent Document (ICD). In the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language will be utilized and completed in accordance with the MDACC "Policy For Consenting Non-English Speaking Participants."
  6. Must have adequate organ and marrow function as follows:(a) leukocytes >/= 3,000/mm^3 (b) absolute neutrophil count >/= 1,500/mm^3 (c) platelets >/= 75,000/mm^3 (d) hemoglobin >/= 8g/dL (e) total bilirubin </= 2 x institutional upper limit of normal (ULN) (f) AST(SGOT)/ALT(SGPT) </= 2.5 x ULN if alkaline phosphatase is normal, or alkaline phosphatase </= 4 x ULN if transaminases are normal (g) Creatinine </= 2.0 x ULN or creatinine clearance >/= 60 mL/min/1.73 m^2
  7. Prior radiotherapy is allowed if: (a) there is measurable disease outside the radiation field OR (b) radiotherapy was completed more than 4 weeks ago and there is clearly recurrent and growing disease within the radiation field.
  8. Must be able to take intact tablets by mouth, or be able to take tablets dissolved in water by mouth or by a percutaneous gastrostomy tube.
  9. Patients - both males and females - with reproductive potential (includes women who are menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures such as barrier methods, condom or diaphragm with spermicide, or abstinence throughout the study. Birth control should continue for 4 weeks after discontinuation of erlotinib therapy. Women of childbearing potential must provide a negative pregnancy test (serum betaHCG) within 72 hours prior to first receiving protocol therapy.
  10. Organ transplant patients are eligible as long as they do not have active signs of rejection and have adequate bone marrow function.

Exclusion Criteria:

  1. Women who are pregnant, breastfeeding, and women and men not practicing effective birth control. Erlotinib is a signal transduction inhibitor agent with the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with erlotinib. Breastfeeding should be discontinued if the mother is treated with erlotinib.
  2. Prior EGFR inhibitor therapy is not allowed (including, but not limited to, erlotinib, gefitinib, cetuximab, panitumumab, vandetanib).
  3. Patients who are receiving any other anticancer or investigational agents at time of study enrollment. Patients may have received one other systemic therapy or investigational agent in the past, but a washout time period of at least 4 weeks and recovery of any treatment-related toxicities to < CTCAEv4 grade 2 is required.
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib.
  5. Patients with a history of an invasive malignancy (other than the one treated in this study) or lymphoproliferative disorder within the past 3 years. Patients with a history of adequately treated non-melanoma skin cancer, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix are allowed.
  6. Patients with incomplete healing from previous surgery.
  7. Patients with pulmonary fibrosis (other than in a radiated field) or active interstitial lung disease.
  8. Patients with active gastrointestinal disease or a disorder that alters gastrointestinal motility or absorption, including lack of integrity of the gastrointestinal tract (for example, a significant surgical resection of the stomach or small bowel, inflammatory bowel disease or uncontrolled chronic diarrhea.
  9. Patients with skin rash ≥ CTCAEv4 grade 2
  10. In the opinion of the investigator, patients with any condition that is unstable or could jeopardize the safety of the patient or could limit compliance with the study's requirements. These include, but are not limited to, ongoing or active infection requiring parenteral antibiotics at time of study registration, psychiatric illness that would limit compliance with study requirements or symptomatic congestive heart failure (NYHA class II or greater), unstable angina pectoris or cardiac arrhythmia requiring maintenance medication.
  11. Patient is unwilling or unable to discontinue prohibited concomitant therapies, (i.e St. John's wort, grapefruit juice, H2 blockers/proton pump inhibitors, strong CYP3A4 inhibitors and inducers).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198028


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
OSI Pharmaceuticals
Investigators
Principal Investigator: Bonnie S. Glisson, MD, BS M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01198028     History of Changes
Other Study ID Numbers: 2009-0888
NCI-2010-02074 ( Registry Identifier: NCI CTRP )
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Squamous cell carcinoma of the skin
Cutaneous squamous cell carcinoma
CSCC
epidermal growth factor receptor
EGFR
tyrosine kinase inhibitor
recurrent
Erlotinib
Erlotinib hydrochloride
OSI-774
Tarceva

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Skin Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action