Overview

This trial is active, not recruiting.

Conditions squamous cell carcinoma of the head and neck, basaloid squamous cell carcinoma, undifferentiated carcinoma, adenosquamous cell carcinoma
Treatments abraxane, erbitux, carboplatin, intensity modulated radiation therapy
Phase phase 1/phase 2
Target EGFR
Sponsor Dana-Farber Cancer Institute
Collaborator Celgene Corporation
Start date November 2007
End date October 2013
Trial size 28 participants
Trial identifier NCT00570674, 07-069

Summary

The purpose of the Phase I part of this research study is to determine the safest and most effective dose of Abraxane when given in combination with carboplatin and Erbitux during radiation therapy for head and neck cancer. The purpose of the Phase II part of this study is to determine the effects of the treatment on head and neck cancers, as well as to further study the safety of this treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
abraxane
Dose will vary depending upon when enrolled on trial. Given as an infusion.
erbitux
One dose is given prior to the start of radiation, then weekly by infusion.
carboplatin
Given weekly as an infusion.
intensity modulated radiation therapy
Monday through Friday for about seven weeks.

Primary Outcomes

Measure
Phase I: To identify the maximally tolerated dose of Abraxane given with carboplatin and Erbitux plus concurrent IMRT.
time frame: 2 years
Phase II: To evaluate the efficacy by evaluating 2-year-disease-free survival.
time frame: 2 years

Secondary Outcomes

Measure
To evaluate the safety and tolerability of the combination of Abraxane, carboplatin and Erbitux.
time frame: 2 years
To estimate the overall response rate to ACE-RT.
time frame: 2 years
To estimate 2-year overall survival.
time frame: 2 years
To evaluate functional outcome at 2 years with respect to speech, swallowing and overall quality of life.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically proven squamous cell carcinoma of th head and neck or its variants. Primary tumor sites eligible include nasopharynx, oral cavity, oropharynx, hypopharynx, larynx, or unknown primary SSCHN. Although they have squamous histology, tumors of the skin, nasal cavity and paranasal sinuses are excluded because their responsiveness to chemotherapy and radiotherapy may differ. - Stage III or IV disease, without evidence of distant metastasis, according to the American Joint Committee on Cancer. - Measurable disease, according to RECIST. - Treatment-naive SSCHN, i.e. no prior chemotherapy, radiotherapy or attempted complete resection. - < CTCAE v3.0 Grade 2 neuropathy - 18 years of age or older - ECOG Performance Status of 0 or 1 - No active alcohol addiction or other condition that, in the opinion of the study investigators, would interfere with the subject's ability to comply with the treatment plan. - Lab values as outlined in the protocol - Negative pregnancy test within 7 days of study entry Exclusion Criteria: - Pregnant or breast-feeding women, or women and men of childbearing potential not willing to use adequate contraception while receiving treatment and for at least 6 months thereafter. - Symptomatic peripheral neuropathy Grade 2 or greater by CTCAE v3.0 - History of other malignancy within the previous 5 years, except for non-melanoma skin cancer, carcinoma in situ of the cervix, bladder or head and neck. - Prior therapeutic radiation to the head and neck - Other serious illness or medical conditions, including but not limited to: unstable cardiac disease or myocardial infarction within 6 months prior to study entry; history of significant neurologic disorder, including advanced dementia or uncontrolled seizure disorder; clinically significant uncontrolled infection; active peptic ulcer disease defined as unhealed or clinically active ulcer; hypercalcemia; active drug addiction including cocaine or intravenous drug use, defined as occuring within 6 months preceding diagnosis; chronic obstructive pulmonary disease; autoimmune disease requiring active therapy; severe psoriasis; chronic uncontrolled diarrhea. - Patients who experienced involuntary weight loss of more than 20% of their body weight in the two months preceding study entry - Concurrent treatment with any other anticancer therapy - Prior therapy that targets the EGFR pathway - Participation in an investigational drug trial within 30 days of study entry

Additional Information

Official title A Phase I/II Trial of Abraxane in Combination With Carboplatin, Erbitux and Intensity Modulated Radiation Therapy (IMRT)for Treatment of Locally Advanced Squamous Cancer of the Head and Neck
Principal investigator Roy B. Tishler, MD
Description - Participants will receive radiation therapy, typically done Monday through Friday for about seven weeks (participants will sign a separate consent form with the radiation oncologist that will outline what to expect from this treatment). - On the first week of the study (in the week prior to the start of radiation) participants will receive one dose of Erbitux only. After that, they will receive all three drugs (Erbitux, Abraxane and Carboplatin) weekly during the 7 weeks of radiation. These drugs are given intravenously. Each participant will receive the same dose of Erbitux and carboplatin. The dose of Abraxane will depend upon when the participant is enrolled in the study and if the maximum tolerated dose has been established. - Participants will be examined every week during the treatment. A physical exam will be performed along with questions about general health and specific questions about any problems the participant is experiencing. - Blood tests will be done every week during treatment and include chemistry and hematology tests. - Participants will be asked to return to the clinic within 8 to 10 weeks of finishing the treatment. The following exams and procedures will be performed during this time: physical exam; blood tests; imaging of the tumor; imaging of the chest and; neck surgery (if the study doctors think that the participant may benefit from surgery to remove lymph nodes in the neck).
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.