OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer

NCT00076310 | Active Not Recruiting Phase 2 Results FDA Drug

• 1 other identifier: ID02-668
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if giving the new drug, Tarceva® (OSI-774), in combination with Platinol® (cisplatin) and Taxotere® (docetaxel) is effective in the treatment of metastatic or recurrent head and neck cancer. The safety of this treatment will also be studied.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Squamous Cell Cancer; OSI-774; Cisplatin; Platinol®-AQ; Platinol®; CDDP; Docetaxel; Taxotere; Tarceva; HNSCC; Erlotinib Hydrochloride

Outcome Measures

Primary Outcomes (1)

• Overall Response Assessment (Radiographic RECIST)

  Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter from the smallest sum diameter recorded, NE = not evaluable

  after 2 cycles of treatment (6 weeks) and confirmed 4-6 weeks thereafter

Secondary Outcomes (2)

• Progression Free Survival and Overall Survival Duration Assessments

  From treatment initiation until 150 months after initiation of treatment

• Toxicity -- Number of Adverse Events

  time of first drug administration to 30 days after last drug administration (maximum of 6 months)

Study Arms (1)

Cisplatin + Docetaxel + OSI-774

EXPERIMENTAL

Cisplatin 75 mg/m\^2 IV every 21 days. Docetaxel 60 mg/m\^2 IV repeated every 21 days. OSI-774 100 mg oral administered daily. May have a dose escalation of 150 mg pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached.

Drug: Docetaxel; Drug: OSI-774; Drug: Cisplatin

Interventions

Docetaxel DRUG

60 mg/m\^2 IV repeated every 21 days.

Also known as: Taxotere

Cisplatin + Docetaxel + OSI-774

OSI-774 DRUG

100 mg oral administered daily. May have a dose escalation of 150 mg pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached.

Also known as: Tarceva, Erlotinib Hydrochloride

Cisplatin + Docetaxel + OSI-774

Cisplatin DRUG

75 mg/m\^2 IV every 21 days.

Also known as: Platinol®-AQ, Platinol®, CDDP

Cisplatin + Docetaxel + OSI-774

Eligibility Criteria

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

You may qualify if:

• Have histologically or cytologically confirmed metastatic or recurrent head and neck squamous cell carcinoma from the primary lesion and/or lymph nodes of the oral cavity, oropharynx, hypopharynx, or larynx.
• Have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease.
• Have not received any prior systemic chemotherapy for metastatic or recurrent head and neck squamous cell carcinoma. If patients have received prior combined modality therapy, they must be off therapy for at least 6 months.
• Be \>= 18 years of age.
• No acute intercurrent illness or infection.
• ECOG performance status =\<2 (Karnofsky =\>60%). Have normal organ and marrow function defined as: leukocytes=\>3,000/uL; absolute neutrophil count=\>1,500/uL; platelets =\>100,000/uL hemoglobin \>= 8g/dl; total bilirubin within normal institutional limits; AST(SGOT)/ALT(SGPT) =\<2.5 X institutional upper limit of normal if alkaline phosphate is \<ULN OR alkaline phosphatase may be up to 4x ULN if transaminases are \<ULN; creatinine =\<2.0 xULN OR creatinine clearance \>60 mL/min/1.73 m\*\*2 for patients with creatinine levels above institutional normal
• The effects of OSI-774 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after the completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• History of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free, are eligible.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients who have had chemotherapy or non-palliative radiotherapy for their recurrent or metastatic head and neck cancer.
• Patients may not be receiving any other investigational agents.
• Brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774 or other agents used in the study.
• Patient has received prior biologic therapy targeting EGFR.
• Signs or symptoms of acute infection requiring systemic therapy.
• Exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent.
• Requires total parenteral nutrition with lipids.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Histology other than squamous cell carcinoma.
• Refusing to sign the informed consent.
• History of severe hypersensitivity reaction to Taxotere®.
• Pre-existing peripheral neuropathy NCI CTC grade 2 or worse.
• Pregnant or lactating women are excluded from this study because OSI-774 is an unknown Class agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774, breastfeeding should be discontinued if the mother is treated with OSI-774. These potential risks may also apply to other agents used in this study.
• Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774, cisplatin, or docetaxel or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• William WN Jr, Tsao AS, Feng L, Ginsberg LE, Lee JJ, Kies MS, Glisson BS, Kim ES. Single Arm, Phase II Study of Cisplatin, Docetaxel, and Erlotinib in Patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas. Oncologist. 2018 May;23(5):526-e49. doi: 10.1634/theoncologist.2017-0661. Epub 2018 Jan 25.

  PMID: 29371473 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms, Squamous Cell; Squamous Cell Carcinoma of Head and Neck

Interventions

Docetaxel; Erlotinib Hydrochloride; Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Xiuning Le, MD
• Organization: MD Anderson Cancer Center

xle1@mdanderson.org

(713) 792-6980

Study Officials

• Xiuning Le, MD

  M.D. Anderson 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: January 20, 2004
• First Posted: January 21, 2004
• Study Start: January 28, 2004
• Primary Completion: May 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2026-04

Locations

US (1)