Trial of RAD001 and Erlotinib With Recurrent Head and Neck Squamous Cell Carcinoma

NCT00942734 | Completed Phase 2 Results

• 2 other identifiers: 2008-0567NCI-2012-01643
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if RAD001 in combination with Tarceva (erlotinib hydrochloride) can help to control head and neck squamous cell cancer (HNSCC). The safety of this drug combination will also be studied.

Conditions

Head And Neck Cancer

Keywords

Head and Neck; Squamous Cell Carcinoma; RAD001; Erlotinib; Everolimus; OSI-774; Tarceva

Outcome Measures

Primary Outcomes (1)

• 12-Week Progression-Free Survival (PFS)

  Tumor assessments performed by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) after 4 weeks, 12 weeks, then every 8 weeks thereafter. Participants who received at least one dose of RAD001+erlotinib and who die before 12 weeks, counted as having progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progression-free survival defined as stable disease or better. Progressive Disease (PD): \>20% increase in sum of LD of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum LD since treatment started.

  12 weeks

Study Arms (1)

RAD001 + Erlotinib

EXPERIMENTAL

RAD001 1 tablet (5 mg) by mouth every day of each 28 day study cycle. Erlotinib one tablet (150 mg) by mouth every day of each 28 day study cycle.

Drug: Erlotinib; Drug: RAD001

Interventions

Erlotinib DRUG

One tablet (150 mg) by mouth every day of each 28 day study cycle.

Also known as: OSI-774, Tarceva

RAD001 + Erlotinib

RAD001 DRUG

1 tablet (5 mg) by mouth every day of each 28 day study cycle.

Also known as: Everolimus

RAD001 + Erlotinib

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
• Patients who had prior induction or concurrent chemotherapy delivered as part of their primary treatment are eligible as long as they have completed primary therapy at least 6 months prior to study entry.
• Patients must have at least one measurable site of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation
• Age \>/= 18 years
• Minimum of two weeks since any major surgery or completion of radiation. Note: Patients may have received prior radiation therapy to tumor sites that will not be assessed for response, unless there is evidence of progression.
• Completion of all prior systemic anticancer therapy for the treatment of recurrent/metastatic disease (adequately recovered from the acute toxicities of any prior therapy) at least 4 weeks prior to study entry
• Eastern Cooperative Oncology Group (ECOG) performance status \</= 2
• Laboratory Values (within 14 days prior to administration of study drugs): Adequate bone marrow function as shown by: absolute neutrophil count (ANC) \>/= 1.5 \* 10\^9/L, Platelets \>/= 100 \* 10\^9/L, Hgb \> 10 g/dL; Adequate liver function as shown by: serum bilirubin \</=1.5 \* upper limit of normal (ULN), and serum transaminases activity \</= 3 \* ULN. With the exception of serum transaminases (\< 5 \* ULN) if the patient has liver metastases
• Signed informed consent

You may not qualify if:

• Prior treatment with any investigational drug within the preceding 4 weeks, concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy, or therapy with agents otherwise used in treatment of cancer (for example, methotrexate for rheumatoid arthritis)
• Chronic treatment with systemic steroids or another immunosuppressive agent. Steroids will not be allowed and should be discontinued 24 hours prior to initiation of treatment on protocol. An exception for replacement steroids prescribed for adrenal insufficiency will be allowed.
• Patients should not receive immunization with attenuated live vaccines during study period or within one week of study entry
• Patients with metastatic disease to the brain, unless treated and controlled and the patient is off steroids and/or antiepileptics for at least 3 weeks.
• Other malignancies within the past 2 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
• Patients with active skin, mucosa, ocular or gastrointestinal disorders grade \> 1
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction, \</= 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia
• A known history of HIV or AIDS-related illness or previous seropositivity for the virus
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study agents (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
• Patients with any condition which impairs the ability to swallow study agent intact
• Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
• Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential (WOCP) must have a negative urine or serum pregnancy test within 7 days prior to administration of study drugs). WOCP: A female of child bearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
• Lack of resolution of all toxic manifestations of prior chemotherapy biologic therapy or radiation therapy.
• Patients who have received prior treatment with an mTor inhibitor.
• Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novartis: collaborator
• OSI Pharmaceuticals: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Massarelli E, Lin H, Ginsberg LE, Tran HT, Lee JJ, Canales JR, Williams MD, Blumenschein GR Jr, Lu C, Heymach JV, Kies MS, Papadimitrakopoulou V. Phase II trial of everolimus and erlotinib in patients with platinum-resistant recurrent and/or metastatic head and neck squamous cell carcinoma. Ann Oncol. 2015 Jul;26(7):1476-80. doi: 10.1093/annonc/mdv194. Epub 2015 May 29.

  PMID: 26025965 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

Erlotinib Hydrochloride; Everolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Vali Papadimitrakopoulou, MD
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Vali Papadimitrakopoulou, MD

  M.D. Anderson Cancer Center

  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: SPONSOR

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 21, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 1, 2025
• Results First Posted: February 4, 2016

Record last verified: 2025-04

Locations

US (1)