RAD001, Cisplatin and Concurrent Radiation for Locally Advanced, Inoperable Head and Neck Cancer

NCT01057277 | Terminated Phase 1 Results DMC

• 1 other identifier: BrUOG-H&N-229
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if RAD001, to a maximum dose of 10 mg/day, can be safely administered with cisplatin, and concurrent radiotherapy, for patients with locally advanced, inoperable, squamous cell carcinoma of the head and neck.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Advanced Inoperable Head & Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Response

  1 year

Study Arms (1)

RAD001(Afinitor)

EXPERIMENTAL

Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47

Drug: RAD001(Afinitor)

Interventions

RAD001(Afinitor) DRUG

Rad001 in combination withCisplatin and Concurrent RT

Also known as: Afinitor

RAD001(Afinitor)

Eligibility Criteria

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

You may qualify if:

• Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx;
• Stage III or IV disease. Patients are unresectable or resection would produce severe impairment or disfiguration.
• Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
• History/physical examination within 4 weeks prior to registration
• Chest x-ray (or Chest CT scan or PET/CT scan) within 6 weeks prior to registration.
• CT scan, Pet CT, or MRI of the head and neck (of the primary tumor and neck nodes).
• Zubrod Performance Status 0-1;
• Age \> 18;
• Adequate bone marrow function, defined as ANC \> 1,500 cells/ul and Platelets \> 100,000 cells/ul and Hgb \> 9mg/dl.
• Bilirubin \< 1.5x upper limit of normal, (For patients with Gilbert's disease as the sole cause of elevated bilirubin, they are eligible if the direct bilirubin is \< than 1.5x upper limit of normal)
• AST or ALT \< 2.5x the upper limit of normal.
• Adequate renal function, defined as follows:
• Creatinine clearance (CC) ≥ 50 ml/min within 2 weeks prior to registration determined by:
• hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CrCl male)
• INR and PTT \< 1.5 x uln. (Anticoagulation is allowed if target INR \< 1.5 on a stable dose of warfarin or a stable dose of LMW heparin for \> 2 weeks prior to starting treatment.)

You may not qualify if:

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3years.
• Patients with simultaneous primaries or bilateral tumors are excluded. Patients with nasopharyngeal cancer and unknown primaries are excluded.
• Gross total excision (e.g., by tonsillectomy) of the primary tumor; however, partial removal of the tumor to alleviate an impending airway obstruction does not make the patient ineligible.
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
• Initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease; radical or modified neck dissection is not permitted.
• Severe, active co-morbidity, defined as follows:
• Current uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure.
• Transmural myocardial infarction within the last 6 months;
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration defined as oxygen saturation that is \< 88% at rest on room air.
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
• Any uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study procedures;
• Prior allergic reaction to the study drug(s) involved in this protocol;
• Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.

Sponsors & Collaborators

• howard safran: lead
• Rhode Island Hospital: collaborator
• The Miriam Hospital: collaborator
• Memorial Hospital of Rhode Island: collaborator
• Roger Williams Medical Center: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Howard Safran, MD
• Organization: Brown University Oncology Research Group (BrUOG)

kayla_rosati@brown.edu

4018633000

Study Officials

• Howard Safran, MD

  Lifespan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: January 27, 2010
• Study Start: December 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 17, 2020
• Results First Posted: August 4, 2015

Record last verified: 2020-02

Locations

US (1)