Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00005087
First received: April 6, 2000
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel, cisplatin, and filgrastim combined with radiation therapy in treating patients who have locally recurrent head and neck cancer and have received previous treatment with radiation therapy.


Condition Intervention Phase
Head and Neck Cancer
Biological: filgrastim
Drug: cisplatin
Drug: paclitaxel
Procedure: conventional surgery
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Paclitaxel and Cisplatin in Combination With Split Course Concomitant Hyperfractionated Re-Irradiation in Patients With Recurrent Squamous Cell Cancer of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From registration to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free Survival [ Time Frame: From registration to 1 year ] [ Designated as safety issue: No ]
  • Grade 4-5 toxicity [ Time Frame: From one year after the start of radiation therapy to last follow-up. ] [ Designated as safety issue: Yes ]
  • Pattern of failure (local-regional, distant, new primary, death) [ Time Frame: From registration to last follow-up. ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: March 2000
Study Completion Date: November 2013
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation (BID) and chemotherapy
Radiation (BID), cisplatin and paclitaxel given on days 1-5 (Monday-Friday) in weeks 1, 3, 5 and 7. G-CSF given on days 6-13.
Biological: filgrastim Drug: cisplatin Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy

Detailed Description:

OBJECTIVES:

  • Determine the median, one-year, and long-term (defined as two-year) disease-free survival and overall survival in patients with previously irradiated locally recurrent squamous cell cancer of the head and neck treated with paclitaxel, cisplatin, and filgrastim (G-CSF) combined with radiotherapy.
  • Determine the rates of acute and late toxic effects of this regimen in these patients.
  • Determine the pattern of disease progression in patients treated with this regimen.

OUTLINE: Patients undergo radiotherapy twice daily (4-6 hours apart) on days 1-5. Patients receive paclitaxel IV over 1 hour beginning immediately after completion of the first fraction of radiotherapy and completing less than 3 hours before starting the second fraction of radiotherapy on days 1-5. Patients receive cisplatin IV over 30 minutes beginning immediately after completion of paclitaxel infusion on days 1-5 and filgrastim (G-CSF) subcutaneously on days 6-13. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who initially respond to therapy but develop a recurrence with a resectable lesion (inside or outside the retreatment field) may undergo surgical resection.

Patients are followed at 4 weeks after completion of radiotherapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 34 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically proven locally recurrent primary squamous cell cancer (SCC) of the head and neck or second primary SCC of the head and neck

    • More than 1 prior recurrence allowed if the first recurrence occurred at least 6 months after completion of prior radiotherapy
  • Disease must be confined to the head and neck (above the clavicles)
  • No primary SCC of the nasopharynx or salivary gland
  • Prior irradiation of 45-75 Gy to the majority (75% or greater) of tumor volume
  • Entire tumor volume must be included in a treatment field that limits the total spinal cord dose (prior and anticipated) to 50 Gy

    • Prior radiotherapy records, including simulation and portal films, available in order to assure that cord tolerance is not exceeded
  • Measurable disease
  • Ineligible for complete surgical resection
  • No distant metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0 or 1

Life expectancy:

  • No other concurrent illness that would limit survival

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • Serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) no greater than 2 times normal*
  • Alkaline phosphatase no greater than 2 times normal*
  • * Greater than 2 times normal allowed if no metastases by liver ultrasound or CT scan

Renal:

  • Creatinine no greater than 1.5 mg/dL

Other:

  • No other invasive malignancy within the past 2 years except in situ malignancies (e.g., carcinoma in situ of the cervix, carcinoma in situ of the breast, or nonmelanoma skin cancer)
  • No other concurrent illness that would impair tolerance to therapy
  • No grade 2 or worse pre-existing peripheral sensory neuropathy
  • No hypersensitivity to E. coli derived products
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Prior chemotherapy allowed as a component of the primary treatment
  • No prior chemotherapy for recurrent disease
  • At least 6 months since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 6 months since prior radiotherapy

Surgery:

  • See Disease Characteristics
  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: NCT00005087

  Show 235 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Corey J. Langer, MD Fox Chase Cancer Center
  More Information

Additional Information:
Publications:
Langer CJ, Harris J, Horwitz EM, et al.: Phase II study of low-dose paclitaxel and cisplatin in combination with split-course concomitant twice-daily reirradiation (XRT) in recurrent squamous cell carcinoma of the head and neck (SCCHN): long-term follow-up of Radiation Therapy Oncology Group (RTOG) protocol 9911. [Abstract] J Clin Oncol 30 (Suppl 15): A-5583, 2012.
Horwitz EM, Harris J, Langer CJ, et al.: Concurrent split course hyperfractionated radiotherapy (Hfx RT), cisplatin (DDP) and paclitaxel (P) in patients with recurrent, previously irradiated squamous cell carcinoma of the head and neck (SCCHN): update of RTOG 9911 . [Abstract] J Clin Oncol 23 (Suppl 16): A-5577, 519s, 2005.
Horwitz EM, Harris J, Langer CJ, et al.: Phase II study of paclitaxel and cisplatin in combination with split course concomitant hyperfractioned re-irradiation in patients with recurrent squamous cell cancer of the head and neck : results of RTOG 99-11. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-119, S72, 2005.
Langer CJ, Harris J, Horwitz E, et al.: Phase II trial of concurrent split course hyperfractionated radiotherapy (Hfx RT), cisplatin (DDP) and paclitaxel (P) in patients with recurrent, previously irradiated squamous cell carcinoma of the head and neck (SCCHN): results of RTOG 9911. [Abstract] J Clin Oncol 22 (Suppl 14): A-5509, 490s, 2004.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00005087     History of Changes
Other Study ID Numbers: RTOG-9911, CDR0000067705
Study First Received: April 6, 2000
Last Updated: January 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
recurrent metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

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

ClinicalTrials.gov processed this record on August 19, 2014