Clinical Trials /

Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma

NCT02541903

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.

Related Conditions:
  • Squamous Cell Carcinoma of the Penis
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
GilotrifGilotrif

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

NameTypeDescriptionInterventions
GilotrifExperimentalGilotrif 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).
  • Gilotrif

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:Progression free survival
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.

Secondary Outcome Measures

Measure:Response rate
Time Frame:Baseline up to 18 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:Recruiting
Lead Sponsor:University of Alabama at Birmingham

Trial Keywords

  • Epidermal growth factor receptor (EGFR),
  • Human Papillomavirus (HPV)
  • Penile squamous cell carcinoma (PSCC)
  • Gilotrif

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