Two-Drug combo aims to stall rare gut tumors
NCT ID NCT00113360
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This trial tests whether combining two drugs—RAD001 (everolimus) and octreotide depot—can slow tumor growth in people with advanced low-grade neuroendocrine cancer (carcinoid or islet cell tumors) that has spread or cannot be removed surgically. Participants take RAD001 daily by mouth and receive octreotide injections every 28 days. The study measures how long the cancer stays under control and monitors safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Everolimus (RAD001) plus octreotide depot
- What this could lead to
- If it works, this combination could offer a new way to slow tumor growth and extend time without progression for people with advanced neuroendocrine cancer.
- What could go wrong
- This is a Phase 2 trial, so the combination may not prove effective or safe enough for broader use. Side effects from the drugs are possible, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
67 people
The number who actually took part.
- Start date
-
Jan 2005
- Finished
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Jul 2009
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * Patients must have recovered from recent surgery. One week must have elapsed from the time of a minor surgery and 4 weeks from major surgery. * Fertile patients, both male and female, must practice contraception during treatment. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
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