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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03194373
Recruitment Status : Completed
First Posted : June 21, 2017
Results First Posted : February 5, 2020
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: Palbociclib Drug: Carboplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 12, 2017
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : March 17, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Palbociclib and Carboplatin

Treatment 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 5, day= 1, cycle length: 21 days

Maintenance Palbociclib after 6 cycles Palbociclib (Ibrance) 125 mg PO daily, days 1-21, cycle length: 28 days

 Drug: Palbociclib

Palbociclib (Ibrance) (PO), dose= 125 mg PO daily, days=1-14, cycle length: 21 days

Maintenance Palbociclib:

Palbociclib (Ibrance) 125 mg PO daily, days 1-21, cycle length: 28 days


Drug: Carboplatin
Carboplatin (IV), dose= AUC 5, day= 1, cycle length: 21 days


Outcome Measures
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Primary Outcome Measures :
  1. Percent Disease Control Rate (DCR) [ Time Frame: 12 weeks ]
    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 :
  1. Median Progression Free Survival Time [ Time Frame: Up to 2 Years ]
    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. Estimated using a Kaplan-Meier analysis.

  2. Median Overall Survival Time [ Time Frame: Up to 2 Years ]
    Overall survival is defined as the time from study enrollment to death from any cause. Estimated using a Kaplan-Meier analysis.

  3. Number of Treatment-related Toxicities [ Time Frame: Up to 2 years ]
    Number of adverse events believed to be related (i.e., possibly, probably, or definitely) to palbociclib in combination with carboplatin, reported by grade according to the Common Terminology for Adverse Events version 4.0 (CTCAE v4).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT03194373


Locations
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United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Paul Swiecicki, M.D. University of Michigan Rogel Cancer Center
  Study Documents (Full-Text)

Documents provided by University of Michigan Rogel Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] October 4, 2018

More Information
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT03194373    
Other Study ID Numbers: UMCC 2017.054
HUM00130055 ( Other Identifier: University of Michigan )
First Posted: June 21, 2017    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
 Neoplasms by Site
Carboplatin
Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action