NCT00030576

Brief Summary

RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with cisplatin may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib and cisplatin in treating patients who have recurrent or metastatic head and neck cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1 head-and-neck-cancer

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_1 head-and-neck-cancer

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

8.1 years

First QC Date

February 14, 2002

Last Update Submit

October 9, 2018

Conditions

Head and Neck Cancer

Keywords

recurrent metastatic squamous neck cancer occult primaryneck cancer with occult primary squamous carcinomastage IV squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxsquamous cell carcinoma of paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of sinus and nasal cavity

Study Arms (1)

OSI-774 and cisplatin

EXPERIMENTAL

HNSCC patients treated in three escalating dose cohorts of daily continous oral erlotinib (OSI-774) and intermittent IV cisplatin given every 21 days

Drug: cisplatinDrug: erlotinib hydrochloride

Interventions

cisplatinDRUG
OSI-774 and cisplatin
erlotinib hydrochlorideDRUG
OSI-774 and cisplatin

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck * All primary sites, including oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, and paranasal sinus * Recurrent, unresectable, and/or metastatic disease * At least 1 measurable lesion * At least 20 mm with conventional techniques OR at least 10 mm with spiral CT scan * Lesions accessible for biopsy * Tumor specimen available for evaluation of epidermal growth factor receptor (EGFR) expression * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy: * More than 12 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Gastrointestinal: * No gastrointestinal tract disease resulting in malabsorption * No requirement for IV alimentation * No active peptic ulcer disease * Inability to swallow tablets or silicon-based G-tubes allowed Ophthalmic: * No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjogren's syndrome) * No congenital abnormality (e.g., Fuch's dystrophy) * No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) * No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except carcinoma in situ of the cervix, nonmelanoma skin cancer, or second primary squamous cell cancer originating from the head and neck * No grade 2 or greater residual ototoxicity or neuropathy from prior platinum-based therapy * No significant traumatic injury within the past 21 days * No other concurrent uncontrolled illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for recurrent or metastatic disease * Prior platinum-based chemotherapy with radiotherapy or platinum-based induction chemotherapy allowed * At least 6 months since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Chemotherapy * At least 4 weeks since prior radiotherapy (except low-dose, limited-fraction palliative non-myelosuppressive radiotherapy \[e.g., involving less than 20% of functioning bone marrow using 800 cGy in 1 fraction or 2,000 cGy in 5 fractions\]) and recovered * No prior radiotherapy to target lesion unless there is evidence of disease progression Surgery: * See Disease Characteristics * At least 21 days since prior major surgery * No prior surgical procedure affecting gastrointestinal absorption Other: * No prior EGFR-targeting therapies * No prior investigational agents for recurrent or metastatic disease * No concurrent combination anti-retroviral therapy for HIV infection * No other concurrent investigational agents * No other concurrent anticancer treatment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L-4M1, Canada

Location

Related Publications (4)

  • Agulnik M, da Cunha Santos G, Hedley D, Nicklee T, Dos Reis PP, Ho J, Pond GR, Chen H, Chen S, Shyr Y, Winquist E, Soulieres D, Chen EX, Squire JA, Marrano P, Kamel-Reid S, Dancey J, Siu LL, Tsao MS. Predictive and pharmacodynamic biomarker studies in tumor and skin tissue samples of patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with erlotinib. J Clin Oncol. 2007 Jun 1;25(16):2184-90. doi: 10.1200/JCO.2006.07.6554.

    PMID: 17538163RESULT

  • Siu LL, Soulieres D, Chen EX, Pond GR, Chin SF, Francis P, Harvey L, Klein M, Zhang W, Dancey J, Eisenhauer EA, Winquist E; Princess Margaret Hospital Phase II Consortium; National Cancer Institute of Canada Clinical Trials Group Study. Phase I/II trial of erlotinib and cisplatin in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: a Princess Margaret Hospital phase II consortium and National Cancer Institute of Canada Clinical Trials Group Study. J Clin Oncol. 2007 Jun 1;25(16):2178-83. doi: 10.1200/JCO.2006.07.6547.

    PMID: 17538162RESULT

  • Winquist E, Soulieres D, Chen E, et al.: A phase II study of erlotinib in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck (PHL002es/NCIC CTG IND.157). [Abstract] Eur J Cancer 2 (Suppl 8): A-408, 122, 2004.

    RESULT

  • Siu LL, Chen X, Tsao M: A phase I/II study of erlotinib (Tarceva) in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck (HNSCC). [Abstract] Clin Cancer Res 9 (16): A-A92, 2003.

    RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

CisplatinErlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Lillian L. Siu, MD, FRCPC

    Princess Margaret Hospital, Canada

    STUDY CHAIR

  • Elizabeth A. Eisenhauer, MD

    Cancer Research Institute at Queen's University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 10, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(6)