Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David Schuller, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00566540
First received: November 30, 2007
Last updated: January 7, 2013
Last verified: December 2012

November 30, 2007
January 7, 2013
December 2007
December 2013   (final data collection date for primary outcome measure)
Feasibility of treatment [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
Feasibility of treatment
Complete list of historical versions of study NCT00566540 on ClinicalTrials.gov Archive Site
  • Disease-free interval and failure sites [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Correlation of molecular markers with treatment outcome [ Time Frame: Up to week 14 ] [ Designated as safety issue: No ]
  • Correlation of quality of life with treatment outcome [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Frequency and severity of toxicities [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]
  • Treatment completion [ Time Frame: up to one year ] [ Designated as safety issue: No ]
    Patients are to be seen at Ohio State Medical center for a physical exam every 2 months for the first year.
  • Disease-free interval and failure sites
  • Correlation of molecular markers with treatment outcome
  • Correlation of quality of life with treatment outcome
  • Frequency and severity of toxicities
  • Treatment completion
Not Provided
Not Provided
 
Ph 2 Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Cancer
Intensification Regimen for Previously Untreated, Resectable, Advanced Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, and Hypopharynx: Incorporation of Intensity Modulated Radiotherapy and Submandibular Gland Transfer to Minimize Treatment Morbidity; Correlative Imaging/Molecular Markers.

RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving cisplatin and paclitaxel together with radiation therapy and surgery works in treating patients with advanced cancer of the oral cavity, oropharynx, or hypopharynx that can be removed by surgery.

OBJECTIVES:

Primary

  • Determine the feasibility of a new intensification regimen comprising cisplatin and paclitaxel in combination with radiotherapy and surgery in patients with resectable advanced squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx.

Secondary

  • Assess the disease-free interval and failure sites in patients treated with this regimen.
  • Correlate molecular markers with treatment outcome in these patients.
  • Correlate quality of life with treatment outcome in these patients.
  • Determine the frequency and severity of toxicities of this regimen in these patients.
  • Evaluate treatment completion in these patients.

OUTLINE:

  • Preoperative therapy (weeks 1 and 2): Patients receive cisplatin IV over 2 hours on days 1-3. Patients also undergo intensity-modulated external beam radiotherapy once daily on days 1-5 and 8-12.
  • Surgery (week 3): Patients undergo surgical resection of the primary tumor (with or without neck dissection) and intraoperative boost radiotherapy.
  • Postoperative therapy (weeks 7-10): Patients receive cisplatin IV over 2 hours on days 1-3 and 22-24 and paclitaxel IV over 3 hours on days 1, 8, 15, and 22. Patients also undergo intensity-modulated external beam radiotherapy on days 1-5, 8-12, 15-19, and 22-26.

Patients undergo blood and tissue sample collection at baseline, in weeks 3, 7-10, and 14, and then periodically thereafter for biomarker correlative studies.

Quality of life is assessed at baseline, at 3, 6, and 12 months after completion of treatment, and then annually thereafter.

After completion of study treatment, patients are followed every 2 months for 1 year and then periodically thereafter.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: Cisplatin
    Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1.
    Other Names:
    • Platinol-®AQ
    • cis-DDP
    • cis-Diamminedichloroplatinum
    • cis-Platinum II
    • DDP
  • Drug: Paclitaxel
    Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10
    Other Name: Taxol®
  • Radiation: Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation
    Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and involved regional nodes 20Gy over 10 daily (M-F) treatments (2 Gy Fractions with 6 millivolts photons)week 1 and 2.
    Other Names:
    • radiation therapy
    • EBT
    • IMRT
  • Procedure: Triple endoscopy and biopsy
    Resection of the primary tumor: Patients must have surgery performed according to the following surgical guidelines. The extent of the surgical resection will be dictated by the extent of the tumor at the time of initial evaluation. The primary lesion must be widely excised using accepted criteria for adequate excision depending on the region involved. All patients will undergo percutaneous endoscopic gastrostomy tube placement at the time of endoscopy and biopsies.
Experimental: Treatment (neoadjuvant, adjuvant chemotherapy and radiation)

PREOPERATIVE:Patients receive cisplatin IV over 2 hours three times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2.

SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3.

INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation.

POSTOPERATIVE: Patients receive paclitaxel IV over 3 hours in weeks 7-10 and cisplatin IV over 1-2 hours three times weekly in weeks 7 and 10. Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation QD, 5 days a week, in weeks 7-10.

Interventions:
  • Drug: Cisplatin
  • Drug: Paclitaxel
  • Radiation: Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation
  • Procedure: Triple endoscopy and biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a Karnofsky Performance Index ≥60%
  • Patients must be over the age of 18.
  • Patients must have a life expectancy of at least 6 months.
  • Women of childbearing age must have a negative serum pregnancy test and agree to use an effective method of contraceptive.
  • Patients with a cardiac history should be cleared with a medical internist. In general, patients with a history of prior bradyarrythmias, atrioventricular (AV) conduction defects or marginal cardiac function will be eligible.
  • Patients must have resectable stage III, stage IVA, stage IVB (without distant metastases) squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx. Hypopharyngeal carcinomas may also be stage II.
  • Patients must not have had prior chemotherapy or radiotherapy (to the primary site or nodes).
  • Patients may not be planning to receive while on study concomitant immunotherapy or hormonal therapy, except oral contraceptives or hormone replacement therapy.
  • Patients must have adequate hepatic function documented by a normal serum bilirubin 0- 1.5mg/L and serum transaminases < 4 x upper limit.
  • Patients must have adequate renal function documented by a serum creatinine not above upper institutional normal limits and/or 24 hour OR calculated creatinine clearance >60 ml/min. using the following formula:

    (140-age) x Wt (kg) x .85 (if Estimated Creatinine Clearance = 72 x Creatinine (mg/dl) female)

  • Patients must have adequate bone marrow function documented by platelet count ≥ 100,000 and absolute neutrophil count ≥ 2,000.
  • Patients will have surgery according to Section 5.3. Operative and pathology reports must be sufficiently detailed to confirm that surgery was done according to the guidelines.
  • Patients must be examined by a multi-modality team (consisting of a head and neck surgeon, medical oncologist, and radiation oncologist) prior to entry on study.
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

  • Distant metastases.
  • Prior malignancy, except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years.
  • Any condition that would be considered a contraindication for fluid challenge.
  • Pregnant or lactating women may not participate.
  • History of demyelinating neurological disorder, such as multiple sclerosis
  • History of pancytopenia or aplastic anemia.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00566540
OSU-06026, NCI-2011-02687
Yes
David Schuller, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: David E. Schuller, MD Ohio State University
Ohio State University Comprehensive Cancer Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP