OSI-774 + Chemotherapy for Head and Neck Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Investigational agents, Antiretrovirals

Disqualifiers: Brain metastases, Psychiatric illness, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 18 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are receiving other investigational agents or certain treatments for HIV. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug combination OSI-774, cisplatin, and docetaxel for head and neck cancer?

Research shows that combining docetaxel and cisplatin is effective in treating head and neck cancer, with response rates of 33% to 44% and improved survival times. Adding docetaxel to cisplatin and 5-fluorouracil has also been shown to improve progression-free and overall survival with less toxicity. ^{1 2 3 4 5}

What safety data exists for the combination of OSI-774, Cisplatin, and Docetaxel in head and neck cancer treatment?

Studies have shown that the combination of Docetaxel and Cisplatin is feasible and has been evaluated for safety in patients with head and neck cancer, with some studies specifically assessing the safety profile of these drugs in combination with other treatments. ^{1 4 5 6 7}

What makes the drug combination of OSI-774, Cisplatin, and Docetaxel unique for head and neck cancer?

The combination of OSI-774 (an epidermal growth factor receptor inhibitor), Cisplatin, and Docetaxel is unique because it integrates a targeted therapy with chemotherapy, potentially enhancing the effectiveness against head and neck cancer by attacking the cancer cells in multiple ways. This approach is different from traditional chemotherapy regimens that typically do not include targeted therapies like OSI-774. ^{1 5 8 9 10}

What is the purpose of this trial?

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.

Research Team

Xiuning Le, M.D., Ph.D.

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults with metastatic or recurrent head and neck squamous cell carcinoma who haven't had systemic chemotherapy for this condition. They must have measurable disease, be in a stable health condition, not pregnant, willing to use contraception, and without severe allergies to the drugs being tested.

Inclusion Criteria

My organs and bone marrow are functioning normally.

I had cancer other than melanoma over 5 years ago and have been cancer-free since.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774 or other agents used in the study

I have received treatment targeting EGFR before.

I am currently being treated for an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive OSI-774 daily, and docetaxel and cisplatin every 3 weeks for 18 weeks

18 weeks

Weekly blood tests, physical exams every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Open-label extension

Participants may continue receiving OSI-774 as long as their cancer responds to treatment

Indefinite, every 3 months assessments

Physical exams, blood tests, imaging every 3 months

Treatment Details

Interventions

• Cisplatin
• Docetaxel
• OSI-774

Trial Overview The trial is testing the effectiveness and safety of combining Tarceva (OSI-774) with Platinol (cisplatin) and Taxotere (docetaxel) in treating advanced head and neck cancer. It aims to see if this new drug combination can help patients.

Participant Groups

Group I: Cisplatin + Docetaxel + OSI-774 Experimental Treatment 3 Interventions

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.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Aventis Pharmaceuticals

Industry Sponsor

Trials

81

Recruited

15,000+

Paul Hudson

Aventis Pharmaceuticals

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Aventis Pharmaceuticals

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Findings from Research

The combination of docetaxel and cisplatin demonstrated a significant overall response rate of 53.7% in patients with locally advanced, recurrent, or metastatic squamous cell carcinoma of the head and neck, indicating its efficacy as a treatment option.

Despite common hematologic and non-hematologic toxicities, the treatment was generally well-tolerated, with serious adverse effects being infrequent due to the use of corticosteroid prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a phase II study of the EORTC Early Clinical Studies Group. Schöffski, P., Catimel, G., Planting, AS., et al.[2020]

Docetaxel shows promising efficacy as a treatment for recurrent squamous cell cancer of the head and neck, with response rates between 33% to 44% when combined with cisplatin, and median survival times of 9.6 to 11 months.

In the neoadjuvant setting, docetaxel has demonstrated response rates greater than 90%, indicating its potential for improving disease-free and overall survival, with ongoing trials comparing its effectiveness to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of docetaxel in the management of squamous cell cancer of the head and neck. Glisson, BS.[2018]

In a phase III study involving 358 patients with advanced head and neck cancer, adding docetaxel to cisplatin and 5-fluorouracil (TPF) improved overall survival and reduced toxicity compared to the PF regimen.

Patients receiving TPF showed a trend towards better health-related quality of life (HRQOL) and experienced greater improvements in swallowing and coughing issues during treatment, suggesting that TPF may enhance patient well-being alongside survival benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term health-related quality of life and symptom control with docetaxel, cisplatin, 5-fluorouracil and cisplatin (TPF), 5-fluorouracil (PF) for induction in unresectable locoregionally advanced head and neck cancer patients (EORTC 24971/TAX 323). van Herpen, CM., Mauer, ME., Mesia, R., et al.[2022]

Induction chemotherapy with docetaxel, cisplatin, and 5-fluorouracil (TPF) significantly improves patient outcomes, providing 4.1 quality-adjusted life years (QALYs) compared to 2.0 QALYs for the standard treatment (PF).

The cost-effectiveness analysis shows that TPF has a cost of £1,782 per QALY gained compared to PF, indicating that TPF is a cost-effective option for treating locally advanced squamous cell carcinoma of the head and neck in the UK.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost utility of docetaxel as induction chemotherapy followed by chemoradiation in locally advanced squamous cell carcinoma of the head and neck. Parthan, A., Posner, MR., Brammer, C., et al.[2018]

The combination of docetaxel, cisplatin, and 5-fluorouracil (5-FU) showed a response rate of 64% in patients at dose level I and 78.3% at dose level II, indicating significant efficacy in treating squamous cell carcinoma of the head and neck (SCCHN).

The treatment was associated with manageable safety concerns, with dose-limiting toxicities including renal toxicity and nausea, and the maximum tolerated dose was reached at level II, suggesting that dose level I is safer and recommended for further testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel, cisplatin and 5-fluorouracil in patients with locally advanced unresectable head and neck cancer: a phase I-II feasibility study. Schrijvers, D., Van Herpen, C., Kerger, J., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a phase II study of the EORTC Early Clinical Studies Group. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

The role of docetaxel in the management of squamous cell cancer of the head and neck. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Short-term health-related quality of life and symptom control with docetaxel, cisplatin, 5-fluorouracil and cisplatin (TPF), 5-fluorouracil (PF) for induction in unresectable locoregionally advanced head and neck cancer patients (EORTC 24971/TAX 323). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Induction docetaxel and S-1 followed by concomitant radiotherapy with low-dose daily cisplatin in locally advanced head and neck carcinoma. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Cost utility of docetaxel as induction chemotherapy followed by chemoradiation in locally advanced squamous cell carcinoma of the head and neck. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Docetaxel, cisplatin and 5-fluorouracil in patients with locally advanced unresectable head and neck cancer: a phase I-II feasibility study. [2020]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Docetaxel and Cisplatin Combination Chemotherapy in Patients with Squamous Cell Carcinomas of the Head and Neck. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Integration of taxanes into primary chemotherapy for squamous cell carcinoma of the head and neck: promise fulfilled? [2019]

9. Greece pubmed.ncbi.nlm.nih.gov

Docetaxel, ifosfamide and cisplatin (DIP) in squamous cell carcinoma of the head and neck. [2018]

10. Belgium pubmed.ncbi.nlm.nih.gov

The chemotherapy of head and neck cancer. [2018]