Capecitabine and Lapatinib Ditosylate in Treating Patients With Squamous Cell Cancer of the Head and Neck

NCT01044433 | Completed Phase 2 Results DMC

• 2 other identifiers: UPCC 15309NCI-2009-01492
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving capecitabine together with lapatinib ditosylate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine and lapatinib ditosylate together works in treating patients with squamous cell cancer of the head and neck.

Conditions

Head and Neck Cancer; Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Salivary Gland Squamous Cell Carcinoma; Stage IV Salivary Gland Cancer; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IV Verrucous Carcinoma of the Larynx; Stage IV Verrucous Carcinoma of the Oral Cavity

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  5 years

Secondary Outcomes (4)

• Response Rate

  5 years

• Disease Control Rate

  5 years

• Progression-free Survival

  5 years

• Number of Participants With Adverse Events and Serious Adverse Events

  5 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine twice daily on days 1-14.

Drug: lapatinib ditosylate; Drug: capecitabine

Interventions

lapatinib ditosylate DRUG

Given orally

Also known as: GSK572016, GW-572016, GW2016, lapatinib, Tykerb

Arm I

capecitabine DRUG

Given orally

Also known as: CAPE, Ro 09-1978/000, Xeloda

Arm I

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed SCCHN
• All primary sites are eligible excluding nasopharyngeal
• Metastatic disease or locally recurrent disease not felt amenable to curative therapy (as determined by a physician)
• ECOG performance status 0-2
• No prior chemotherapy in the metastatic / locally advanced, recurrent incurable setting; patients may have received prior curative-intention chemotherapy including induction chemotherapy, chemotherapy concurrent with radiation and adjuvant chemotherapy
• No prior capecitabine; patients who have received 5-FU or other fluoropyrimidines in the curative-intention setting will not be excluded, as long as more than 6 mos have elapsed since prior 5-FU exposure
• No previous history of Lapatinib
• Patients may have received radiation therapy in the definitive, adjuvant or metastatic setting; radiation therapy must be completed at least 14 days prior to study participation
• ECOG performance status of 0-2 (Karnofsky \>= 60%)
• Must have normal organ and marrow function
• Laboratory tests should be completed within 14 days prior to registration
• Left ventricular ejection fraction (LVEF) can be determined by either echocardiography or nuclear scintigraphy and should be obtained within 21 days of enrollment
• Platelets \>= 100,000/mm\^3
• Total bilirubin =\< 2
• Albumin \> 2.5

You may not qualify if:

• Patients who have received prior capecitabine chemotherapy or lapatinib
• Patients with brain metastases may participate if they have undergone appropriate treatment for the lesion(s), are at least two weeks post treatment without evidence for post-treatment progression, have no significant neurologic symptoms, and are no longer on steroids for brain metastases
• Patients with symptoms concerning for CNS metastases should be evaluated with imaging prior to study participation
• Less than 3 weeks elapsed since prior exposure to chemotherapy
• LVEF \< 50% or symptomatic congestive heart failure (CHF)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded due to the potential for teratogenic or abortifacient effects of capecitabine and lapatinib; because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued prior to participation of the mother on study
• Have received treatment within the last 30 days prior to study entry with any drug that has not received regulatory approval for an indication at the time of study entry
• Anti-cancer therapy (other than the investigational regimen) is prohibited from 3 weeks before the first dose of investigational product through discontinuation unless otherwise noted
• Investigational drugs are not permitted from 3 weeks (21 days) or 5 half-lives, whichever is longer, prior to the first dose and up through 30 days after the last dose of investigational product
• CYP3A4 inducers and inhibitors, antacids, and herbal or dietary supplements
• Concurrent radiation therapy and surgery for SCCHN is prohibited during therapy

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Salivary Gland Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Lapatinib; N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl-6-(5-((methylsulfonyl)ethyl)aminomethyl)-2-furyl)-4-quinazolinamine; Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. Corey Langer
• Organization: Abramson Cancer Center

Corey.Langer@uphs.upenn.edu

215-615-5121

Study Officials

• Corey Langer

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: December 10, 2009
• First Posted: January 7, 2010
• Study Start: October 1, 2009
• Primary Completion: September 24, 2015
• Study Completion: March 3, 2017
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Locations

US (1)