Description:
Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease.
Supportive evidence for the value of systemic therapy does not exist for this disease and
there are no agents currently approved by regulatory agencies. This study will evaluate the
drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif
has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins
that are also found in PSCC. The drug has the potential for some patients to exhibit a
response contributing to a greater quality of life.
Title
- Brief Title: Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma
- Official Title: A Phase 2 Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma Following Systemic Therapy
Clinical Trial IDs
- ORG STUDY ID:
F150330009 (UAB 14113)
- NCT ID:
NCT02541903
Conditions
- Penile Squamous Cell Carcinoma (PSCC)
Interventions
Drug | Synonyms | Arms |
---|
Gilotrif | | Gilotrif |
Purpose
Penile squamous cell carcinoma (PSCC) is a highly aggressive and relatively rare disease.
Supportive evidence for the value of systemic therapy does not exist for this disease and
there are no agents currently approved by regulatory agencies. This study will evaluate the
drug Gilotrif in patients with metastatic progressive PSCC following chemotherapy. Gilotrif
has shown supportive evidence in non-small cell lung cancer by inhibiting certain proteins
that are also found in PSCC. The drug has the potential for some patients to exhibit a
response contributing to a greater quality of life.
Detailed Description
This is a non-randomized trial phase 2 trial in which the drug Gilotrif will be administered
at an oral dosage of 40 mg daily. This will continue until there is disease progression or
severe toxicities. Patients will undergo a clinical exam every 4 weeks as well as have blood
collected. Radiographic scans will be done every 8 weeks.
Trial Arms
Name | Type | Description | Interventions |
---|
Gilotrif | Experimental | Gilotrif will be administered orally at 40 mg dosage once daily. Continuous administration of 4 weeks is considered one cycle. Therapy will continue until progression of the disease or severe toxicities. Labs will be monitored with routine blood collections every cycle and a CT scan will be done every two cycles (8 weeks). | |
Eligibility Criteria
Inclusion Criteria:
1. Histologically or cytologically confirmed PSCC.
2. Patients with metastatic or locally advanced unresectable PSCC.
3. Progressive disease after ≥1 prior chemotherapy regimens.
4. Measurable disease by RECIST 1.1 criteria.
5. Prior regimen within 6 months
6. ECOG performance status 0-2.
7. Adequate organ function, defined as all of the following:
- Absolute neutrophil count (ANC) >1500 /mm3. Platelet count >100,000/ mm3.
- Estimated creatinine clearance ≥ 45ml/min.
- Total Bilirubin <1.5 times upper limit of institutional normal; Aspartate amino
transferase (AST) or alanine amino transferase (ALT) <2.5 times the upper limit
of institutional normal (ULN).
- Hemoglobin ≥8.5 g/dl.
8. Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to
NCI CTCAE version 4.03 grade <1, in the opinion of the Treating Physician.
9. Ability to understand and willingness to sign a written informed consent. Age ≥18
years or age of majority at the participating site, whichever is greater.
10. Availability of 20 archival formalin-fixed paraffin embedded tumor tissue slides.
Exclusion Criteria:
1. Patients will have recovered from toxicities from prior systemic anticancer treatment
or local therapies.
2. Prior EGFR inhibitors.
3. Major surgery within 4 weeks or minor surgery within 2 weeks before registration or
scheduled for surgery during the projected course of the study. Wounds will be
completely healed prior to study entry and patients recovered from all toxicities from
surgery. Placement of vascular access device is not considered major or minor surgery
in this regard.
4. Prior radiation therapy is allowed as long as the irradiated area was not the sole
source of measurable disease and radiotherapy was completed with recovery from
toxicity, at least 3 weeks prior to enrollment. If the irradiated area is the only
site of disease, there will be progressive disease.
5. History or presence of clinically relevant cardiovascular abnormalities such as
uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA)
classification of 3, unstable angina or poorly controlled arrhythmia as determined by
the investigator. Myocardial infarction within 6 months prior to registration.
6. Any history of or concomitant condition that, in the opinion of the Investigator,
would compromise the patient's ability to comply with the study or interfere with the
evaluation of the efficacy and safety of the test drug.
7. Previous or concomitant malignancies at other sites, except effectively treated
non-melanoma skin cancers, ductal carcinoma in situ or effectively treated malignancy
that has been in remission for more than 3 years and is considered to be cured.
8. Requiring treatment with any of the prohibited concomitant medications listed in the
protocol that cannot be stopped for the duration of trial participation.
9. Known pre-existing interstitial lung disease.
10. Any history or presence of poorly controlled gastrointestinal disorders that could
affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis,
chronic diarrhea, malabsorption).
11. Active hepatitis B infection (defined as presence of Hep BsAg and/ or Hep B DNA),
active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV
carrier.
12. Meningeal carcinomatosis.
13. Patients with active brain or subdural metastases are not eligible, unless they have
completed local (radiation) therapy and have discontinued the use of corticosteroids
or have been on stable dose of corticosteroids for at least 4 weeks before starting
study treatment. Any symptoms attributed to brain metastases will be stable for at
least 4 weeks before starting study treatment.
14. Any active or uncontrolled infection.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of Participants With Progression Free Survival at 6 Months |
Time Frame: | 6 months following study treatment |
Safety Issue: | |
Description: | Death will signify the time of progression free survival. Otherwise, the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 will be used to evaluate disease progression. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
Secondary Outcome Measures
Measure: | Response Rate |
Time Frame: | Baseline up to 3 months |
Safety Issue: | |
Description: | The Response Evaluation Criteria in Solid Tumors guidelines version 1.1 and disease assessment scans (bone, CT) will be used to evaluate tumor response. |
Measure: | Overall Survival |
Time Frame: | Baseline to death (assessed up to 30 months). |
Safety Issue: | |
Description: | From date of study enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 30 months. |
Measure: | Toxicities |
Time Frame: | Baseline up to 18 months |
Safety Issue: | |
Description: | The number of adverse events and serious adverse events will be tabulated using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | University of Alabama at Birmingham |
Trial Keywords
- Epidermal growth factor receptor (EGFR),
- Human Papillomavirus (HPV)
- Penile squamous cell carcinoma (PSCC)
- Gilotrif
Last Updated
April 14, 2020