RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

NCT00576680 | Completed Phase 1 Results DMC

• 1 other identifier: 07-325
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

Brief Summary

This research study will test the safety of RAD001 in combination with temozolomide.

Conditions

Pancreatic Neuroendocrine Tumor

Keywords

RAD001; temozolomide

Outcome Measures

Primary Outcomes (1)

• Response Rate

  To determine the objective response rate by RECIST criteria of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. Partial response (PR) by these criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.

  2 years

Secondary Outcomes (2)

• Progression-free Survival

  2 years

• To Determine the Safety and Tolerability of This Drug Combination.

  2 years

Study Arms (1)

Temozolomide with RAD001

EXPERIMENTAL

Drug: RAD001; Drug: Temozolomide

Interventions

RAD001 DRUG

Given orally once a day

Temozolomide with RAD001

Temozolomide DRUG

Taken orally once a day for one week followed by a one-week break period

Also known as: Temodar

Temozolomide with RAD001

Eligibility Criteria

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

You may qualify if:

• Locally unresectable or metastatic pancreatic neuroendocrine tumor
• Radiologic, operative, or pathology reports should document a pancreatic location of tumor
• Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma
• Patients must have at least one measurable site of disease according to RECIST criteria that has not been preciously irradiated
• years of age or older
• Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
• Prior treatment with chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine
• No Prior therapy with RAD001 or any other mTOR inhibitor
• ECOG Performance status 0,1 or 2
• Life expectancy 12 weeks or more
• Adequate bone marrow, liver and renal function as outlined in the protocol
• Negative serum pregnancy test
• Fasting serum cholesterol as outlined in protocol

You may not qualify if:

• Prior treatment with any investigational drug within the preceding 4 weeks
• Chronic treatment with systemic steroids or another immunosuppressive agent
• Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry
• Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
• Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
• Women who are pregnant or breast feeding
• Patients who have received prior treatment with an mTOR inhibitor or temozolomide
• Patients with known hypersensitivity to RAD001 or other rapamycins or to its excipients
• History of noncompliance to medical regimens

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Novartis: collaborator
• Schering-Plough: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Adenoma, Islet Cell

Interventions

Everolimus; Temozolomide

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jennifer Chan
• Organization: Dana-Farber Cancer Institute

jang@partners.org

617-632-6315

Study Officials

• Jennifer Chan, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: December 17, 2007
• First Posted: December 19, 2007
• Study Start: May 1, 2008
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: July 9, 2020
• Results First Posted: July 9, 2020

Record last verified: 2020-06

Locations

US (3)