Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Palbociclib

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Enzyme Inhibitors

PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.

Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.

PD 0332991

Douglas Adkins, M.D.

The purpose of this Phase I/II study is to define the maximum tolerated dose of PD 0332991 given with cetuximab and evaluated the side effects of the combination.

PD 0332991 and Cetuximab in Patients With Incurable SCCHN

Phase I/II Trial of the Addition of PD 0332991 to Cetuximab in Patients With Incurable SCCHN

MTD is the dose level (DL) immediately below the DL at which 2 patients of a cohort experience dose limiting toxicity (DLT) in the 1st cycle (DLTs) Hematologic DLT is any of the below that occur during the 1st cycle that are possibly, probably, or definitely related to the treatment grade 4 neutropenia ≥7 days grade 4 infection with grade 3/4 neutropenia grade 4 thrombocytopenia with life-threatening bleeding treatment held for \>14 days due to hematologic toxicity febrile neutropenia with temperature \>=38.5°C

Non-hematologic DLT is any possibly, probably, or definitely related grade 3 or 4 non-hematologic toxicity that occurs during the 1st except for suboptimally treated grade 3 or 4 nausea, vomiting, diarrhea, anorexia, or lymphopenia grade 3 metabolic abnormalities (limited to potassium, magnesium, and calcium) any hypersensitivity/infusion reaction or acneiform rash due to cetuximab treatment held for \>14 days due to non-hematologic toxicity

Tumor measurements will be collected at baseline, end of every even numbered cycles, and end of treatment.

Measured by overall response rate (ORR=CR+PR) defined by RECIST criteria

Best overall response is the best response recorded from the start of treatment until disease progression/recurrence

Complete Response (CR) is defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis).

Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters

Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Participants were followed every 2 months for up to 5 years or until death, whichever occurs first.

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Participants were followed every 2 months for up to 5 years or until death, whichever occurs first.

Overall survival is measured from time of diagnosis to time of death.

Duration of overall response is measured from the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented.

Pfizer

Washington University School of Medicine

PD 0332991 100 mg per day will be administered on Days 1 through 21 of each 28 day cycle.

Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.

Phase I: Dose Level 1

PD 0332991 125 mg per day will be administered on Days 1 through 21 of each 28 day cycle.

Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.

Phase I: Dose Level 2

Phase II Arm 1: Platin-Resistant HPV-Unrelated SCCHN

Phase II Arm 2: Cetuximab-Resistant HPV-Unrelated SCCHN

Phase II Arm 3:

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Douglas R. Adkins, M.D.

* PD 0332991 will be administered on Days 1 through 21 of each 28 day cycle.
* Dose Level 1 PD 0332991 100 mg per day
* Dose Level 2 PD 0332991 125 mg per day

Cetuximab will be administered intravenously on a weekly schedule. The first dose will be 400 mg/m2. The remaining weekly dose will be 250 mg/m2. Participants will continue to receive weekly cetuximab at 250 mg/m2 for the duration of their participation on study.

Phase I: Dose Level 1 and Dose Level 2

Only Phase I participants were evaluable for this outcome measure.

Phase I - Maximum Tolerated Dose (MTD)

Phase I participants were excluded from this outcome measure. 2 participants in Phase II Arm 1 were not evaluable due to early death and inability to measure the target lesion on the post-treatment non-contrast CT scan. 5 participants in Phase II Arm 2 were not evaluable due to comorbidity-related death (N=2), patient withdrawal (N=2), and non-treatment related adverse event (N=1).

Phase II: Efficacy as Measured by Overall Response Rate

Grades 1-2 Neutropenia

Grade 3 Neutropenia

Grades 1-2 Anemia

Grade 3 Anemia

Grades 1-2 Thrombocytopenia

Grade 3 Thrombocytopenia

Grades 1-2 Fatigue

Grade 3 Fatigue

Grades 1-2 Nausea

Grade 3 Nausea

Grade 1-2 Vomiting

Grade 3 Vomiting

Grade 1-2 Diarrhea

Grade 3 Diarrhea

Grade 1-2 Infusion Reaction

Grade 3 Infusion Reaction

Grade 1-2 Acneiform Rash

Grade 3 Acneiform Rash

Grade 1-2 Hypomagnesemia

Grade 3 Hypomagnesemia

Phase I: Most Frequent Adverse Events

Grades 1-2 platelet count decreased

Grades 3-5 platelet count decreased

Grades 1-2 neutrophil count decreased

Grades 3-5 neutrophil count decreased

Grades 1-2 white blood cell count decreased

Grades 3-5 white blood cell count decreased

Grades 1-2 electrocardiogram QT corrected interval prolonged

Grades 3-5 electrocardiogram QT corrected interval prolonged

Phase II Arm 1, Arm 2, and Arm 3

All arms of the Phase II Portion of the study were combined for this outcome measure as the treatment received was the same for each arm.

Phase II: PD 0332991 Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events

Grades 1-2 acneiform rash

Grades 3-5 acneiform rash

Grades 1-2 hypomagnesemia

Grades 3-5 hypomagnesemia

Phase II: Cetuximab Related Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events

Grades 1-2 fatigue

Grades 3-5 fatigue

Grades 1-2 hypoalbuminemia

Grades 3-5 hypoalbuminemia

Grades 1-2 anemia

Grades 3-5 anemia

Grades 1-2 hyponatremia

Grades 3-5 hyponatremia

Grades 1-2 hypertension

Grades 3-5 hypertension

Grades 1-2 nausea

Grades 3-5 nausea

Grades 1-2 dysphagia

Grades 3-5 dysphagia

Grades 1-2 dyspnea

Grades 3-5 dyspnea

Grades 1-2 hypocalcemia

Grades 3-5 hypocalcemia

Grades 1-2 lymphocyte count decreased

Grades 3-5 lymphocyte count decreased

Grades 1-2 diarrhea

Grades 3-5 diarrhea

Grades 1-2 weight loss

Grades 3-5 weight loss

Grades 1-2 AST increased

Grades 3-5 AST increased

Grades 1-2 tumor pain

Grades 3-5 tumor pain

Grades 1-2 constipation

Grades 3-5 constipation

Grades 1-2 cough

Grades 3-5 cough

Grades 1-2 anorexia

Grades 3-5 anorexia

Grades 1-2 vomiting

Grades 3-5 vomiting

Grades 1-2 dry mouth

Grades 3-5 dry mouth

Grades 1-2 sinus tachycardia

Grades 3-5 sinus tachycardia

Grades 1-2 alkaline phosphatase increased

Grades 3-5 alkaline phosphatase increased

Grades 1-2 hypokalemia

Grades 3-4 hypokalemia

Grades 1-2 hyperglycemia

Grades 3-5 hyperglycemia

Grades 1-2 hypernatremia

Grades 3-5 hypernatremia

Grades 1-2 fever

Grades 3-5 fever

Grades 1-2 dizziness

Grades 3-5 dizziness

Grades 1-2 hypercalcemia

Grades 3-5 hypercalcemia

Grades 1-2 dry skin

Grades 3-5 dry skin

Grades 1-2 dehydration

Grades 3-5 dehydration

Grades 1-2 hypotension

Grades 3-5 hypotension

Grades 1-2 creatinine increased

Grades 3-5 creatinine increased

Grades 1-2 trismus

Grades 3-5 trismus

Grades 1-2 elevated INR

Grades 3-5 elevated INR

Grades 1-2 dysarthria

Grades 3-5 dysarthria

Grades 1-2 hypophosphatemia

Grades 3-5 hypophosphatemia

Grades 1-2 lung infection

Grades 3-5 lung infection

Grades 1-2 febrile neutropenia

Grades 3-5 febrile neutropenia

Grade 1-2 abdominal pain

Grades 3-5 abdominal pain

Grades 1-2 colitis

Grades 3-5 colitis

Grades 1-2 tumor hemorrhage

Grades 3-5 tumor hemorrhage

Grades 1-2 hematuria

Grades 3-5 hematuria

Grades 1-2 duodenal ulcer

Grades 3-5 duodenal ulcer

Grades 1-2 esophageal fistula

Grades 3-5 esophageal fistula

Grades 1-2 oral cavity fistula

Grades 3-5 oral cavity fistula

Grades 1-2 sepsis

Grades 3-5 sepsis

Grades 1-2 duodenal perforation

Grades 3-5 duodenal perforation

Grades 1-2 skin infection

Grades 3-5 skin infection

Grades 1-2 tracheitis

Grades 3-5 tracheitis

Grades 1-2 aspiration

Grades 3-5 aspiration

Grades 1-2 pleural effusion

Grades 3-5 pleural effusion

Phase II: Arm 1, Arm 2, and Arm 3

Phase II: Adverse Events Occurring in 10% or More of Participants and All Grade 3-5 Adverse Events

Spots Global Cancer Trial Database for PD 0332991 and Cetuximab in Patients With Incurable SCCHN

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Interventions

Study Description

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