Iressa Study in Patients With Salivary Gland Cancer

NCT00509002 | Completed Phase 2 Results

• 2 other identifiers: 2004-0089NCI-2010-00744
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if ZD1839 (Iressa®, gefitinib can help to shrink or slow the growth of advanced, recurrent, or metastatic salivary gland cancer. The safety of this drug will also be studied.

Conditions

Salivary Gland Cancer

Keywords

Salivary Gland Cancer; Iressa; ZD1839

Outcome Measures

Primary Outcomes (1)

• Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy

  The modified Response Evaluation Criteria in Solid tumors (RECIST) criteria was used for objective tumor response assessment. Complete Response (CR): Disappearance all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): \>20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or \> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Response rate estimated by Gehan's Phase II clinical trial design.

  Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal

Study Arms (2)

Adenoid Cystic Salivary Gland Carcinoma Group

EXPERIMENTAL

Participants receive Gefitinib daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.

Drug: Gefitinib

Other Carcinoma of Salivary Gland Group

EXPERIMENTAL

Participants receive Gefitinib daily by mouth until progressive disease, unacceptable toxicity or patient withdrawal.

Drug: Gefitinib

Interventions

Gefitinib DRUG

250 mg by mouth once a day, every day, at about same time in morning.

Also known as: Iressa, ZD1839

Adenoid Cystic Salivary Gland Carcinoma Group; Other Carcinoma of Salivary Gland Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed salivary gland carcinoma.
• Patients with advanced or recurrent salivary gland cancer who are not candidates for curative surgery or radiotherapy.
• Measurable disease per the RECIST criteria. For disease occurring in previously irradiated field, there must be confirmed progression prior to the date registration and more than three months after completion of radiotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Prior central nervous system (CNS) involvement by tumor is permissible if previously treated and clinically stable for two weeks after completion of treatment.
• At least a 2-week recovery from prior therapy toxicity.
• Provision of written informed consent.
• Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (IUD, birth control pills, or barrier device) during and for 3 months after completion of trial therapy.

You may not qualify if:

• Known severe hypersensitivity to or any of the excipients of this product.
• Other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma, squamous cell carcinoma of the skin, or cervical cancer in situ.
• Concomitant use of phenytoin, carbamazepine, rifampicin, phenobarbital, or St John's Wort or CYP3A4 (e.g. itraconazole, ketoconazole)
• Treatment with a investigational drug within 28 days before Day 1 of trial treatment.
• Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy (except alopecia)
• Incomplete healing from previous surgery.
• Serum creatinine level greater than CTC grade 2.
• Women who are pregnant or breast feeding.
• Prior or other EGFR inhibiting agents.
• Serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR).
• Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
• Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases.
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
• Uncontrolled seizure disorder, active neurological disease, or greater than Grade 2 neuropathy.
• Keratoconjunctivitis sicca or incompletely treated eye infection.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Jakob JA, Kies MS, Glisson BS, Kupferman ME, Liu DD, Lee JJ, El-Naggar AK, Gonzalez-Angulo AM, Blumenschein GR Jr. Phase II study of gefitinib in patients with advanced salivary gland cancers. Head Neck. 2015 May;37(5):644-9. doi: 10.1002/hed.23647. Epub 2015 Mar 30.

  PMID: 24585506 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: George R Blumenschein Jr, MD, Professor, Thoracic/Head & Neck Med. Oncology
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-7734

Study Officials

• George Blumenschein, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: May 1, 2004
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 24, 2017
• Results First Posted: November 24, 2017

Record last verified: 2017-10

Locations

US (1)