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Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar

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ClinicalTrials.gov Identifier: NCT00476476
Recruitment Status : Completed
First Posted : May 22, 2007
Results First Posted : March 19, 2015
Last Update Posted : May 7, 2015
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Squamous Cell Carcinoma
Intervention Drug: Erlotinib
Enrollment 41

Recruitment Details Patients enrolled from February 2007 through July 2011.
Pre-assignment Details  
Arm/Group Title Erlotinib-Cohort 1 Erlotinib-Cohort 2
Hide Arm/Group Description Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day. Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
Period Title: Overall Study
Started 17 24
Response Evaluable 17 23 [1]
Completed 15 0 [2]
Not Completed 2 24
Reason Not Completed
Adverse Event             2             7
Progressive Disease             0             17
[1]
One woman was unevaluable due to an allergic reaction that developed after the 2nd dose.
[2]
Treatment was not of fixed duration and thus pts are not considered to have 'Completed' treatment.
Arm/Group Title Erlotinib-Cohort 1 Erlotinib-Cohort 2 Total
Hide Arm/Group Description Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day. Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day. Total of all reporting groups
Overall Number of Baseline Participants 17 24 41
Hide Baseline Analysis Population Description
The analysis population is comprised of all enrolled patients.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants 24 participants 41 participants
75
(58 to 94)
71.5
(49 to 86)
73
(49 to 94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 24 participants 41 participants
Female
17
 100.0%
24
 100.0%
41
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 24 participants 41 participants
17 24 41
1.Primary Outcome
Title Response Rate
Hide Description Response is defined as achieving complete or partial response.Complete response (CR) for both cohorts was defined as resolution of all identified tumor masses on the vulva or disappearance of all target and non-target lesions with no evidence of new lesions documented by two disease assessments at least 4 weeks apart. For cohort 1 pts, a partial response (PR) was defined as a 30% reduction in the product of all diameters of the vulva tumor/tumors compared to baseline measurements. For cohort 2 pts, PR defined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was at least a 30% decrease in the sum of the longest diameter (LD) of all target measurable lesions (baseline sum LD reference).
Time Frame Assessed prior to definitive surgery or chemoradiation therapy (cohort 1 pts) or after 2 cycles of therapy (cohort 2 pts).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis dataset is comprised of response evaluable patients.
Arm/Group Title Erlotinib-Cohort 1 Erlotinib-Cohort 2
Hide Arm/Group Description:
Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
Overall Number of Participants Analyzed 17 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion of participants
.35
(.167 to .580)
.22
(.09 to .404)
Time Frame Assessed from time of first dose, weekly during treatment and through 30 days post-treatment.
Adverse Event Reporting Description

Serious AEs were defined as treatment-related events of grade 3 or higher per CTCAEv3.

Other AEs were defined as treatment-related events of grades 1 or 2 per CTCAEv3.

 
Arm/Group Title Erlotinib
Hide Arm/Group Description Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
All-Cause Mortality
Erlotinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Erlotinib
Affected / at Risk (%)
Total   19/41 (46.34%) 
Blood and lymphatic system disorders   
Hemoglobin  1  2/41 (4.88%) 
Ear and labyrinth disorders   
Hearing w/w-o audiogr in monitor prg  1  2/41 (4.88%) 
Gastrointestinal disorders   
Colitis  1  1/41 (2.44%) 
Diarrhea w/o prior colostomy  1  7/41 (17.07%) 
Nausea  1  3/41 (7.32%) 
Vomiting  1  1/41 (2.44%) 
General disorders   
Fatigue  1  2/41 (4.88%) 
Infections and infestations   
Infection-other  1  1/41 (2.44%) 
Investigations   
Death - disease progression NOS  1 [1]  2/41 (4.88%) 
Bilirubin  1  1/41 (2.44%) 
Creatinine  1  1/41 (2.44%) 
Metabolism and nutrition disorders   
Anorexia  1  1/41 (2.44%) 
Dehydration  1  3/41 (7.32%) 
Hypercalcemia  1  1/41 (2.44%) 
Hyperglycemia  1  1/41 (2.44%) 
Hypophosphatemia  1  1/41 (2.44%) 
Hypokalemia  1  3/41 (7.32%) 
Hyponatremia  1  2/41 (4.88%) 
Musculoskeletal and connective tissue disorders   
Nonneuropathic generalized weakness  1  1/41 (2.44%) 
Bone, pain  1  1/41 (2.44%) 
Psychiatric disorders   
Confusion  1  1/41 (2.44%) 
Renal and urinary disorders   
Renal failure  1  3/41 (7.32%) 
Urinary retention  1  1/41 (2.44%) 
Reproductive system and breast disorders   
Perineum, pain  1  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/41 (2.44%) 
Hypoxia  1  1/41 (2.44%) 
Pneumothorax  1  1/41 (2.44%) 
Pulmonary/Upper Respiratory-other  1  1/41 (2.44%) 
Skin and subcutaneous tissue disorders   
Rash/desquamation  1  1/41 (2.44%) 
Rash: acne/acneiform  1  1/41 (2.44%) 
Hand-foot reaction  1  1/41 (2.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Organ System N/A
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Erlotinib
Affected / at Risk (%)
Total   40/41 (97.56%) 
Blood and lymphatic system disorders   
Hemoglobin  1  8/41 (19.51%) 
Hematologic-other  1  1/41 (2.44%) 
Cardiac disorders   
Sinus tachycardia  1  1/41 (2.44%) 
Endocrine disorders   
Endocrine-other  1  1/41 (2.44%) 
Eye disorders   
Dry eye syndrome  1  1/41 (2.44%) 
Eyelid dysfunction  1  1/41 (2.44%) 
Tearing  1  1/41 (2.44%) 
Ocular-other  1  2/41 (4.88%) 
Gastrointestinal disorders   
Constipation  1  4/41 (9.76%) 
Diarrhea w/o prior colostomy  1  23/41 (56.10%) 
Dry mouth  1  3/41 (7.32%) 
Flatulence  1  1/41 (2.44%) 
Dyspepsia  1  1/41 (2.44%) 
Muco/stomatitis by exam, oral cavity  1  1/41 (2.44%) 
Nausea  1  6/41 (14.63%) 
Vomiting  1  7/41 (17.07%) 
GI-other  1  3/41 (7.32%) 
Abdomen, pain  1  2/41 (4.88%) 
Peritoneum, pain  1  1/41 (2.44%) 
General disorders   
Fatigue  1  23/41 (56.10%) 
Fever w/o neutropenia  1  2/41 (4.88%) 
Edema limb  1  7/41 (17.07%) 
Pain-other  1  8/41 (19.51%) 
Flu-like syndrome  1  1/41 (2.44%) 
Infections and infestations   
Infection w/ gr3-4 neut, anal/perianal  1  1/41 (2.44%) 
Infection Gr0-2 neut, lung  1  1/41 (2.44%) 
Infection Gr0-2 neut, oral cavity  1  1/41 (2.44%) 
Infection Gr0-2 neut, urinary tract  1  3/41 (7.32%) 
Infection w/ unk ANC urinary tract NOS  1  1/41 (2.44%) 
Injury, poisoning and procedural complications   
Chemoradiation dermatitis  1  1/41 (2.44%) 
Investigations   
Leukocytes  1  1/41 (2.44%) 
Platelets  1  1/41 (2.44%) 
Weight loss  1  3/41 (7.32%) 
Alkaline phosphatase  1  3/41 (7.32%) 
ALT, SGPT  1  2/41 (4.88%) 
AST, SGOT  1  5/41 (12.20%) 
Bilirubin  1  1/41 (2.44%) 
Creatinine  1  5/41 (12.20%) 
Metabolic/Laboratory-other  1  2/41 (4.88%) 
Metabolism and nutrition disorders   
Anorexia  1  11/41 (26.83%) 
Dehydration  1  7/41 (17.07%) 
Hypoalbuminemia  1  8/41 (19.51%) 
Bicarbonate  1  1/41 (2.44%) 
Hypercalcemia  1  1/41 (2.44%) 
Hypocalcemia  1  3/41 (7.32%) 
Hyperglycemia  1  4/41 (9.76%) 
Hypermagnesemia  1  1/41 (2.44%) 
Hypomagnesemia  1  7/41 (17.07%) 
Hypophosphatemia  1  1/41 (2.44%) 
Hyperkalemia  1  1/41 (2.44%) 
Hypokalemia  1  4/41 (9.76%) 
Hyponatremia  1  1/41 (2.44%) 
Musculoskeletal and connective tissue disorders   
Back, pain  1  2/41 (4.88%) 
Buttock, pain  1  1/41 (2.44%) 
Neck, pain  1  1/41 (2.44%) 
Nervous system disorders   
Taste disturbance  1  3/41 (7.32%) 
Dizziness  1  1/41 (2.44%) 
Head/headache  1  2/41 (4.88%) 
Psychiatric disorders   
Anxiety  1  2/41 (4.88%) 
Depression  1  1/41 (2.44%) 
Renal and urinary disorders   
Incontinence urinary  1  1/41 (2.44%) 
Urinary frequency/urgency  1  1/41 (2.44%) 
Renal/GU-other  1  4/41 (9.76%) 
Reproductive system and breast disorders   
Vagina, hemorrhage  1  3/41 (7.32%) 
Perineum, pain  1  4/41 (9.76%) 
Vagina, pain  1  3/41 (7.32%) 
Vaginal discharge (non-infectious  1  1/41 (2.44%) 
Respiratory, thoracic and mediastinal disorders   
Chylothorax  1  1/41 (2.44%) 
Cough  1  6/41 (14.63%) 
Dyspnea  1  3/41 (7.32%) 
Pulmonary/Upper Respiratory-other  1  1/41 (2.44%) 
Skin and subcutaneous tissue disorders   
Erythema multiforme  1  1/41 (2.44%) 
Skin breakdown/decubitus ulcer  1  1/41 (2.44%) 
Dry skin  1  12/41 (29.27%) 
Alopecia  1  6/41 (14.63%) 
Hyperpigmentation  1  1/41 (2.44%) 
Nail changes  1  1/41 (2.44%) 
Pruritus/itching  1  2/41 (4.88%) 
Rash/desquamation  1  5/41 (12.20%) 
Rash: acne/acneiform  1  17/41 (41.46%) 
Ulceration  1  1/41 (2.44%) 
Skin-other  1  2/41 (4.88%) 
Scalp, pain  1  1/41 (2.44%) 
Vascular disorders   
Hypertension  1  2/41 (4.88%) 
Hemorrhage-other  1  3/41 (7.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Neil Horowitz MD
Organization: Dana-Farber Cancer Institute
Phone: 617.732.8843
Responsible Party: Neil S. Horowitz, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00476476     History of Changes
Other Study ID Numbers: 06-174
First Submitted: May 18, 2007
First Posted: May 22, 2007
Results First Submitted: March 8, 2015
Results First Posted: March 19, 2015
Last Update Posted: May 7, 2015