RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma

NCT00113360 | Completed Phase 2 Results

• 1 other identifier: 2004-0597
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Primary endpoint:

• Assess the clinical activity of RAD 001 plus depot octreotide as defined by progression free survival (PFS) duration defined by RECIST criteria in treated and untreated patients with metastatic, unresectable low grade neuroendocrine carcinoma. Secondary endpoints:
• Assess the progression free survival duration of patients with metastatic, unresectable low grade neuroendocrine carcinoma treated with RAD 001 plus depot octreotide.
• Assess the safety of RAD 001 plus depot octreotide in patients with metastatic, unresectable low grade neuroendocrine carcinoma.
• To determine the expression/phosphorylation status of the components of the mTOR signaling pathway in the primary tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and octreotide.
• To determine the effect of the combination of RAD001 and octreotide on the expression and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify potential pharmacodynamics markers of response to this drug combination.
• To observe the effects of treatment with RAD001 on plasma angiogenic biomarkers.

Conditions

Neuroendocrine Carcinoma; Islet Cell Carcinoma

Keywords

Neuroendocrine Carcinoma; Low Grade Neuroendocrine Carcinoma; Neuroendocrine Carcinoid; Islet Cell Carcinoma; RAD001; Everolimus; Octreotide Depot; Sandostatin LAR; Octreotide long-acting release (LAR); Octreotide LAR

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is measured from date of trial entry until documented progression of disease or death from any cause. PFS is measured by computed tomography (CT) scans or magnetic resonance imaging (MRI) performed at baseline and after every three cycles.

  PFS assessed every 12 weeks (at the end of every 3 cycles) or more frequently if clinically indicated

Study Arms (1)

RAD001 plus Depot Octreotide

EXPERIMENTAL

RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days.

Drug: RAD001; Drug: Octreotide Depot

Interventions

RAD001 DRUG

Starting dose of 5 or 10 mg by mouth daily.

Also known as: Everolimus

RAD001 plus Depot Octreotide

Octreotide Depot DRUG

30 mg injection into the muscle of either buttock once every 28 (±7) days.

Also known as: Sandostatin LAR, Octreotide long-acting release (LAR), Octreotide LAR

RAD001 plus Depot Octreotide

Eligibility Criteria

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

You may qualify if:

• Patients with histologic proof of low grade neuroendocrine carcinoma will be eligible. Both carcinoid (any site\[atypical/intermediate grade carcinoid is allowed\]) and islet cell (pancreatic endocrine tumor) will be eligible.
• Patients with neuroendocrine tumors associated with MEN1 syndrome will be eligible.
• Patients must have either metastatic or unresectable local-regional cancer.
• Patients must have measurable disease, as defined by RECIST (Response Evaluation Criteria In Solid Tumors).
• Prior and concurrent octreotide (Sandostatin and Sandostatin LAR) is allowed.
• Prior radiation therapy is permitted. A recovery period of at least 4 weeks after completion of radiotherapy is required prior to enrollment.
• Patients may have received 0, 1, or 2 prior cytotoxic chemotherapy.
• Chemotherapy used as a radiosensitizer will be considered one prior chemotherapy regimen.
• Patients may have received prior interferon (not counted toward prior cytotoxic chemotherapy).
• Patients may have received prior therapy targeting c-kit, abl, PDGFR (Platelet Derived Growth Factor Receptor), VEGF (Vascular endothelial growth factor), or EGFR \[epidermal growth factor receptor\] (not counted toward prior cytotoxic chemotherapy).
• Patients may have had prior hepatic artery embolization. There must be residual measurable disease. Chemoembolization will be considered as one prior chemotherapy regimen.
• Patients must have a performance status of 0, 1, or 2 (Zubrod scale).
• Patients must be \>/= 18 years old (age limit due to lack of adequate safety data in younger patients).
• Patients must give written informed consent.
• Patients should have adequate organ function defined as follows: Absolute granulocytes \> 1,500/mm3, hemoglobin \> 8 g/dl, and platelets \> 100,000/mm3. Serum bilirubin \< 1.5 x Upper Limit of Normal (ULN), serum creatinine \< 1.5 mg/dL, AST (SGOT) less/equal 2.5 x ULN, ALT (SGPT) less/equal 2.5 x ULN.

You may not qualify if:

• Patients may receive no other concurrent chemotherapy, immunotherapy, or radiotherapy.
• Patients with intolerance to octreotide.
• Patients who have received chemotherapy, immunotherapy, or investigational therapy in the 30 days prior to registration.
• Patients with uncontrolled diabetes mellitus as defined by fasting blood sugar \> 1.5 x ULN.
• Pregnant or lactating women. All women of child-bearing potential must have a negative pregnancy test prior to entry into the study. All patients of child-bearing potential must be advised of the importance of avoiding pregnancy and using appropriate methods of contraception while participating in this investigational trial. Women who have had menses within the past 2 years, who have not had a tubal ligation, or bilateral oophorectomy are considered to be of child-bearing potential. Appropriate methods of contraception include hormonal or barrier method of birth control; abstinence.
• Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
• Psychiatric disorders rendering them incapable of complying with the requirements of the protocol.
• Osseous metastasis as only site of disease.
• Any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for \> 5 years will be allowed to enter the trial.

Sponsors & Collaborators

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

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center website

MeSH Terms

Conditions

Carcinoma, Neuroendocrine; Carcinoma, Islet Cell

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; 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

Results Point of Contact

• Title: James Yao, M.D./Associate Professor
• Organization: UT M. D. Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-2828

Study Officials

• James Yao, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2005
• First Posted: June 8, 2005
• Study Start: January 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 1, 2025
• Results First Posted: December 7, 2010

Record last verified: 2025-04

Locations

US (1)