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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00942734
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Head And Neck Cancer Drug: Erlotinib Drug: RAD001 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of the Combination of RAD001 and Erlotinib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
Study Start Date : July 2009
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: RAD001 + Erlotinib
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
One tablet (150 mg) by mouth every day of each 28 day study cycle.
Other Names:
  • OSI-774
  • Tarceva

Drug: RAD001
1 tablet (5 mg) by mouth every day of each 28 day study cycle.
Other Name: Everolimus

Primary Outcome Measures :
  1. 12-Week Progression-Free Survival (PFS) [ Time Frame: 12 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
  2. Patients that have failed one platinum-containing chemotherapy regimen with or without EGFR inhibitor and/or epidermal growth factor receptor (EGFR) inhibitor as systemic therapy for recurrent/metastatic disease. Prior investigational therapy (with the exclusion of mammilian target of rapamycin (mTOR) inhibitor) allowed but at least 4 weeks must have elapsed with recovery from all toxicities
  3. 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.
  4. 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
  5. Age >/= 18 years
  6. 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.
  7. 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
  8. Eastern Cooperative Oncology Group (ECOG) performance status </= 2
  9. 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
  10. Continued from Inclusion # 9: Fasting serum cholesterol </= 300 mg/dL OR </= 7.75 mmol/L AND fasting triglycerides </= 2.5 * ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication
  11. Signed informed consent

Exclusion Criteria:

  1. 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)
  2. 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.
  3. Patients should not receive immunization with attenuated live vaccines during study period or within one week of study entry
  4. 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.
  5. Other malignancies within the past 2 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
  6. Patients with active skin, mucosa, ocular or gastrointestinal disorders grade > 1
  7. 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
  8. Continued from Exclusion #7: severely impaired lung function; uncontrolled diabetes as defined by fasting serum glucose >1.5x ULN; any active (acute or chronic) or uncontrolled infection/ disorders.; nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy; liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
  9. A known history of HIV or AIDS-related illness or previous seropositivity for the virus
  10. 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).
  11. Patients with any condition which impairs the ability to swallow study agent intact
  12. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
  13. 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).
  14. (Continued from Exclusion # 13) Females must either commit to abstinence from heterosexual intercourse or use a barrier method of contraception. Oral, implantable, and injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Males must either commit to abstinence from heterosexual intercourse or use a barrier method of contraception.
  15. Lack of resolution of all toxic manifestations of prior chemotherapy biologic therapy or radiation therapy.
  16. Patients who have received prior treatment with an mTor inhibitor.
  17. Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
  18. Patients with psychiatric illness or confusional status that may impair the patient's understanding of the informed consent
  19. Patients unwilling to or unable to comply with the protocol
  20. Patients with any condition which impairs the ability to swallow study agent intact

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00942734

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
OSI Pharmaceuticals
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Principal Investigator: Vali Papadimitrakopoulou, MD M.D. Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00942734    
Other Study ID Numbers: 2008-0567
NCI-2012-01643 ( Registry Identifier: NCI CTRP )
First Posted: July 21, 2009    Key Record Dates
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016
Last Verified: January 2016
Keywords provided by M.D. Anderson Cancer Center:
Head and Neck
Squamous Cell Carcinoma
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs