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Paclitaxel, Carboplatin and Cetuximab (PCC) Versus Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01154920
First received: June 29, 2010
Last updated: November 20, 2014
Last verified: November 2014
  Purpose

The goal of this clinical research study is to learn which chemotherapy combination is more effective in treating locally advanced head and neck squamous cell carcinoma. The side effects of these combinations will also be studied.


Condition Intervention Phase
Head and Neck Squamous Cell Carcinoma
Drug: Paclitaxel
Drug: Carboplatin
Drug: Cetuximab
Drug: Docetaxel
Drug: Cisplatin
Drug: Fluorouracil
Radiation: Radiotherapy (RT)
Other: Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial Contrasting Weekly Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Progression-Free Survival (PFS) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    PFS defined as the time from the first day of treatment until the date of objective progressive disease (PD) (locoregional or distant) or death (by any cause in the absence of PD is first reported.


Estimated Enrollment: 128
Study Start Date: July 2010
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCC Group + RT
Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT)
Drug: Paclitaxel
135 mg/m^2 weekly, Weeks 1 - 6
Other Name: Taxol
Drug: Carboplatin
AUC of 2 weekly, Weeks 1 - 6
Other Name: Paraplatin
Drug: Cetuximab
400 mg/m^2 by vein once Week 1; 250 mg/m^2 weekly for Weeks 2 - 6.
Other Names:
  • C225
  • Erbitux
  • IMC-C225
Radiation: Radiotherapy (RT)
Radiation about 2-4 weeks after induction therapy, Monday through Friday for about 7 weeks, or as recommended by the treating radiologist.
Other Names:
  • Radiation Therapy
  • RT
Experimental: PCC Group + RT + Chemotherapy
Group A: Paclitaxel, Carboplatin and Cetuximab (PCC) Induction + Radiation (RT) + Chemotherapy
Drug: Paclitaxel
135 mg/m^2 weekly, Weeks 1 - 6
Other Name: Taxol
Drug: Carboplatin
AUC of 2 weekly, Weeks 1 - 6
Other Name: Paraplatin
Drug: Cetuximab
400 mg/m^2 by vein once Week 1; 250 mg/m^2 weekly for Weeks 2 - 6.
Other Names:
  • C225
  • Erbitux
  • IMC-C225
Radiation: Radiotherapy (RT)
Radiation about 2-4 weeks after induction therapy, Monday through Friday for about 7 weeks, or as recommended by the treating radiologist.
Other Names:
  • Radiation Therapy
  • RT
Other: Chemotherapy
PCC group receives 6 and C-TPF group receives 3 chemotherapy treatment cycles. If receiving radiation + chemotherapy, weekly Cisplatin 40 mg/m^2 by vein over 1-3 hours or Carboplatin AUC 2 by vein over 1 hour beginning 2 to 3 weeks after conclusion of induction program.
Other Name: Chemoradiotherapy
Experimental: C-TPF Group + RT
Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT)
Drug: Cetuximab
400 mg/m^2 by vein over about 1-2 hours on Day 1; 250 mg/m^2 weeks 2, 4, 5, 7 & 8.
Drug: Docetaxel
75 mg/m^2 by vein over 1 hour on Day 1 of each 21 day cycle for 3 cycles of induction therapy
Other Name: Taxotere
Drug: Cisplatin
100 mg/m^2 by vein over 1-3 hours on Day 1 of each 21 day cycle for 3 cycles of induction therapy
Other Names:
  • Platinol-AQ
  • Platinol
  • CDDP
Drug: Fluorouracil
700 mg/m^2 continuous infusion Days 1-4 on Day 1 of each 21 day cycle for 3 cycles of induction therapy
Other Names:
  • 5-Fluorouracil
  • 5-FU
  • Adrucil
  • Efudex
Radiation: Radiotherapy (RT)
Radiation about 2-4 weeks after induction therapy, Monday through Friday for about 7 weeks, or as recommended by the treating radiologist.
Other Names:
  • Radiation Therapy
  • RT
Experimental: C-TPF Group + RT + Chemotherapy
Group B: Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) Induction + Radiation (RT) + Chemotherapy
Drug: Cetuximab
400 mg/m^2 by vein over about 1-2 hours on Day 1; 250 mg/m^2 weeks 2, 4, 5, 7 & 8.
Drug: Docetaxel
75 mg/m^2 by vein over 1 hour on Day 1 of each 21 day cycle for 3 cycles of induction therapy
Other Name: Taxotere
Drug: Cisplatin
100 mg/m^2 by vein over 1-3 hours on Day 1 of each 21 day cycle for 3 cycles of induction therapy
Other Names:
  • Platinol-AQ
  • Platinol
  • CDDP
Drug: Fluorouracil
700 mg/m^2 continuous infusion Days 1-4 on Day 1 of each 21 day cycle for 3 cycles of induction therapy
Other Names:
  • 5-Fluorouracil
  • 5-FU
  • Adrucil
  • Efudex
Radiation: Radiotherapy (RT)
Radiation about 2-4 weeks after induction therapy, Monday through Friday for about 7 weeks, or as recommended by the treating radiologist.
Other Names:
  • Radiation Therapy
  • RT
Other: Chemotherapy
PCC group receives 6 and C-TPF group receives 3 chemotherapy treatment cycles. If receiving radiation + chemotherapy, weekly Cisplatin 40 mg/m^2 by vein over 1-3 hours or Carboplatin AUC 2 by vein over 1 hour beginning 2 to 3 weeks after conclusion of induction program.
Other Name: Chemoradiotherapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with biopsy-proven squamous cell carcinoma of the oropharynx, oral cavity, nasopharynx, hypopharynx, or larynx.
  2. Biopsy material sufficient for HPV status determination available
  3. Patients should have stage IV disease, stage T0-4 N2b-2c/3 M0 (for nasopharynx patients, stage N1 is eligible). Measurable disease in either the T or N site by RECIST is required.
  4. Patients with stage Tx primary disease are eligible if there is N2b-c/3 lymphadenopathy
  5. ECOG PS 0-1
  6. Age >/= 18 years
  7. Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC >/= 1500 cells/mm^3 and platelet count >/= 100,000 cells/mm^3; adequate hepatic function with bilirubin </= ULN (excluding Gilbert's disease), AST and ALT may be up to 2.5 x ULN if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4 x ULN if AST and ALT are normal. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
  8. Creatinine clearance >/=40 ml/min determined by 24 hour collection or nomogram:CrCl male = (140 - age) x (wt in kg)/serum Cr x 72 or CrCl female = 0.85 x (CrCl male)
  9. Patients should have no serious acute or chronic co-morbid condition, or acute infection, which in the judgment of the attending physician would affect administration of the induction chemotherapy regimens.
  10. Patients must sign a study-specific informed consent form

Exclusion Criteria:

  1. Histology other than squamous cell carcinoma
  2. Proven distant metastases (below the clavicle) by clinical or radiographic measures
  3. ECOG>1
  4. Prior chemotherapy, within the previous 3 years
  5. Prior radiotherapy to the head and neck
  6. Prior cetuximab therapy or prior therapy with any other drug that targets the EGFR pathway
  7. Initial surgical resection rendering the patient clinically and radiologically disease free
  8. Simultaneous primary invasive cancers, excluding superficial non-melanoma skin cancers
  9. Patients with a history of another malignancy (excluding non melanoma skin cancers, and cancers treated > 3 years prior for which patient remains continuously disease free
  10. Men and women of childbearing potential (WOCBP) unwilling to consent to using effective contraception while on treatment and for at least 3 months thereafter
  11. Women who are pregnant or breastfeeding
  12. Pre-existing peripheral neuropathy CTCAE Grade 2 or worse
  13. Hemoglobin < 8.0g/dL
  14. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  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 ClinicalTrials.gov identifier: NCT01154920

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 20115
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Dana-Farber Cancer Institute
Investigators
Study Chair: Vali Papadimitrakopoulou, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01154920     History of Changes
Other Study ID Numbers: 2009-0885, NCI-2012-01773
Study First Received: June 29, 2010
Last Updated: November 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
HNSCC
Paclitaxel
Carboplatin
Cetuximab
Docetaxel
Taxotere
Cisplatin
Platinol-AQ
Platinol
CDDP
Fluorouracil
5-FU
Adrucil
Efudex
chemotherapy
radiation
Chemoradiotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Carboplatin
Cetuximab
Cisplatin
Docetaxel
Fluorouracil
Paclitaxel
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014