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Abraxane in Combination With Carboplatin, Erbitux and IMRT for Locally Advanced Squamous Cancer of the Head and Neck

This study is ongoing, but not recruiting participants.
Celgene Corporation
Information provided by (Responsible Party):
Roy B. Tishler, MD, Dana-Farber Cancer Institute Identifier:
First received: December 10, 2007
Last updated: March 9, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Squamous Cell Carcinoma of the Head and Neck
Basaloid Squamous Cell Carcinoma
Undifferentiated Carcinoma
Adenosquamous Cell Carcinoma
Drug: Abraxane
Drug: Erbitux
Drug: Carboplatin
Radiation: Intensity Modulated Radiation Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Phase I: To identify the maximally tolerated dose of Abraxane given with carboplatin and Erbitux plus concurrent IMRT. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Phase II: To evaluate the efficacy by evaluating 2-year-disease-free survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of the combination of Abraxane, carboplatin and Erbitux. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To estimate the overall response rate to ACE-RT. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To estimate 2-year overall survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate functional outcome at 2 years with respect to speech, swallowing and overall quality of life. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: November 2007
Estimated Study Completion Date: June 2016
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Abraxane Drug: Abraxane
Dose will vary depending upon when enrolled on trial. Given as an infusion.
Drug: Erbitux
One dose is given prior to the start of radiation, then weekly by infusion.
Drug: Carboplatin
Given weekly as an infusion.
Radiation: Intensity Modulated Radiation Therapy
Monday through Friday for about seven weeks.

Detailed 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).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00570674

Sponsors and Collaborators
Dana-Farber Cancer Institute
Celgene Corporation
Principal Investigator: Roy B. Tishler, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Roy B. Tishler, MD, Radiation Oncologist, Dana-Farber Cancer Institute Identifier: NCT00570674     History of Changes
Other Study ID Numbers: 07-069 
Study First Received: December 10, 2007
Last Updated: March 9, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No
Plan Description: No plans to share individual participant data. However, cumulative results will be posted here and also published.

Keywords provided by Dana-Farber Cancer Institute:

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Neoplasms, Complex and Mixed
Albumin-Bound Paclitaxel
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on December 02, 2016