Clinical Trials /

Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

NCT03194373

Description:

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug combination of palbociclib (Ibrance) plus carboplatin in patients with metastatic head and neck squamous cell cancer.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
  • Official Title: A Multi-Center Open Label Single Arm Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: UMCC 2017.054
  • SECONDARY ID: HUM00130055
  • NCT ID: NCT03194373

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DrugSynonymsArms
PalbociclibPalbociclib and Carboplatin
CarboplatinPalbociclib and Carboplatin

Purpose

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug combination of palbociclib (Ibrance) plus carboplatin in patients with metastatic head and neck squamous cell cancer.

Trial Arms

NameTypeDescriptionInterventions
Palbociclib and CarboplatinExperimentalTreatment with Palbociclib and Carboplatin for up to 6 cycles: Palbociclib (Ibrance) (PO), dose= 125 mg PO daily, days=1-14, cycle length: 21 days Carboplatin (IV), dose= AUC 6, day= 1, cycle length: 21 days Maintenance Palbociclib after 6 cycles Palbociclib (Ibrance) 125 mg PO daily, days 1-21, cycle length: 28 days
  • Palbociclib
  • Carboplatin

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically documented progressive squamous cell head and neck cancer with or
             without metastases, not amenable to curative treatment; or the patient has documented
             refusal of curative treatment.

          -  ECOG performance status of 0-2. Eastern Cooperative Oncology Group Performance Status:
             an attempt to quantify cancer patients' general well-being and activities of daily
             life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.

          -  Presence of measurable disease by CT scan per RECIST v1.1.

          -  Age ≥18 years.

          -  Life expectancy of ≥12 weeks.

          -  Women of childbearing potential must have a negative serum or urine pregnancy test at
             time of screening and confirmed within 3 days prior to treatment. Women not of
             child-bearing potential will be defined as all women older than age 50 and anovulatory
             for 12 months.

          -  Signed and dated informed consent document indicating that the patient (or legally
             acceptable representative) has been informed of all pertinent aspects of the trial
             prior to enrollment.

          -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory
             tests, and other study procedures.

          -  Adequate organ and marrow function

        Exclusion Criteria:

          -  Previous treatment with cytotoxic chemotherapy therapy in the recurrent/metastatic
             setting. Previous treatment with non-cytotoxic agents in the recurrent/metastatic
             setting is permitted. Gastrointestinal abnormalities causing impaired absorption
             precluding administration of oral medications.

          -  Evidence of untreated or progressive brain metastases, spinal cord compression, or
             carcinomatous meningitis.

          -  A serious uncontrolled medical disorder or active infection that would impair their
             ability to receive study treatment.

          -  Dementia or significantly altered mental status that would prohibit the understanding
             or rendering of informed consent and compliance with the requirements of this
             protocol.

          -  Patients (male and female) having procreative potential who are not willing or not
             able to use adequate contraception. Women who are pregnant or breast-feeding.

          -  Patients residing in prison.

          -  Prior experimental therapy within 30 days of enrollment.

          -  Availability of curative treatment option for the patient's cancer, whether surgery,
             chemotherapy, radiation, or combination thereof, unless the patient has documented
             refusal of curative treatment.

          -  Current use or anticipated inability to avoid use of drugs that are known strong
             CYP3A4/5 inhibitors (atazanavir, boceprevir, conivaptan, clarithromycin, grapefruit or
             grapefruit juice, indinavir, itraconazole, ketoconazole, nelfinavir, nefazodone,
             posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole ).

          -  Current use or anticipated inability to avoid use of drugs that are known strong
             CYP3A4/5 inducers (carbamazepine, dexamethasone, fosphenytoin, phenytoin,
             phenobarbital, rifabutin, rifampin, rifapentine, St. John's wort).

          -  Patients with a history of severe allergic reaction to cisplatin or carboplatin
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percent Disease Control Rate (DCR)
Time Frame:12 weeks
Safety Issue:
Description:The primary clinical objective of this trial is to estimate disease control rate (DCR) at 12 weeks in patients with metastatic head and neck squamous cell cancer treated with carboplatin and palbociclib. DCR will be defined as either CR (Complete Response: Disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.), PR (Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.) or SD (Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.) at 12 weeks.

Secondary Outcome Measures

Measure:Progression Free Survival Time
Time Frame:Up to 2 Years
Safety Issue:
Description:Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Measure:Overall Survival Time
Time Frame:Up to 2 Years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Michigan Cancer Center

Last Updated

November 30, 2017