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 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: UMCC 2017.054HUM00130055
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Percent Disease Control Rate (DCR)

  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.

  12 weeks

Secondary Outcomes (3)

• Median Progression Free Survival Time

  Up to 2 Years

• Median Overall Survival Time

  Up to 2 Years

• Number of Treatment-related Toxicities

  Up to 2 years

Study Arms (1)

Palbociclib and Carboplatin

EXPERIMENTAL

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; Drug: Carboplatin

Interventions

Palbociclib DRUG

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

Palbociclib and Carboplatin

Carboplatin DRUG

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

Palbociclib and Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (3)

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

palbociclib; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Paul Swiecicki, M.D.
• Organization: University of Michigan Rogel Cancer Center

pswiecic@med.umich.edu

734-647-1017

Study Officials

• Paul Swiecicki, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 21, 2017
• Study Start: October 12, 2017
• Primary Completion: February 1, 2019
• Study Completion: March 17, 2020
• Last Updated: April 12, 2021
• Results First Posted: February 5, 2020

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)