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

NCT00566540 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: OSU-06026NCI-2011-02687
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the hypopharynx

Outcome Measures

Primary Outcomes (1)

• Feasibility of Treatment

  Determine the feasibility of a new intensification regimen for previously untreated resectable advanced stage head and neck cancer that incorporates Cisplatin, Paclitaxel combined with surgery, submandibular gland transfer and radiation therapy

  Up to one year

Secondary Outcomes (4)

• Disease-free Interval and Failure Sites

  Up to one year

• Correlation of Quality of Life With Treatment Outcome

  Up to one year

• Percentage of Participants With Serious Adverse Events

  Up to one year

• Treatment Completion

  up to one year

Other Outcomes (1)

• Correlation of Molecular Markers With Treatment Outcome

  Up to week 14

Study Arms (1)

Treatment (neoadjuvant, adjuvant chemotherapy and radiation)

EXPERIMENTAL

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.

Drug: Cisplatin; Drug: Paclitaxel; Radiation: Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation; Procedure: Triple endoscopy and biopsy

Interventions

Cisplatin DRUG

Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1.

Also known as: Platinol-®AQ, cis-DDP, cis-Diamminedichloroplatinum, cis-Platinum II, DDP

Treatment (neoadjuvant, adjuvant chemotherapy and radiation)

Paclitaxel DRUG

Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10

Also known as: Taxol®

Treatment (neoadjuvant, adjuvant chemotherapy and radiation)

Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation 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.

Also known as: radiation therapy, EBT, IMRT

Treatment (neoadjuvant, adjuvant chemotherapy and radiation)

Triple endoscopy and biopsy PROCEDURE

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.

Treatment (neoadjuvant, adjuvant chemotherapy and radiation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Paclitaxel; Radiotherapy, Intensity-Modulated; Radiotherapy; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Therapeutics; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

The study was stopped in the early stages and no data analysis was completed and results produced.

Results Point of Contact

• Title: Enzer Ozer, MD
• Organization: The Ohio State University Comprehensive Cancer Center

enver.ozer@osumc.edu

614-293-8074

Study Officials

• Enver Ozer, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 3, 2007
• Study Start: December 11, 2007
• Primary Completion: February 25, 2010
• Study Completion: February 25, 2010
• Last Updated: November 26, 2021
• Results First Posted: November 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)