Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Adenoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Herbal and Botanical

Metformin

Cola

Patients randomized to Metformin-ER 500 mg once daily for one week and then escalation to 1000 mg/day for the duration of the trial. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days.

Patients will not receive any study drug from the time of colonoscopy until surgery.

500 mg by mouth once daily, beginning the day after colonoscopy for one week, and then escalation to 1000 mg/day. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days.

Metformin ER

Patrick Lynch, MD, JD

The goal of this clinical research study is to learn more about the possible effects of metformin extended release (ER) in patients with colon cancer or adenomas who are about to have surgery. The safety of this drug will also be studied.

Metformin-ER is commonly used to control blood sugar levels in patients with diabetes. It is also designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.

* If you are in Group 1, you will receive metformin ER. You will have a 2 in 3 chance of being assigned to Group 1.
* If you are in Group 2, you will receive no treatment. You will have a 1 in 3 chance of being assigned to Group 2.

Study Drug Administration:

If you are in Group 1, You will start taking the drug the day after your colonoscopy (or later if your surgery is scheduled to be more than 30 days after the colonoscopy) and will continue to take it until your scheduled surgery (for up to 30 days). During the first week you will take one tablet of metformin-ER by mouth one time each day with food. From the beginning of the second week until your scheduled surgery, you will take two tablets of metformin-ER by mouth one time each day with food. If you have side effects, your dose may be lowered.

If you are in Group 2, you will not receive any study drug from the time of your colonoscopy until surgery.

Study Visits:

On the day of your colonoscopy:

* Your medical history will be recorded and you will be asked about any drugs you may be taking.
* You will have a physical exam.
* Extra tissue samples will be collected during the colonoscopy for routine and biomarker testing. Biomarkers are small pieces of material or substances found in you tissue that may provide information about your condition or the disease.
* The study staff will call you 1 week after your colonoscopy and ask about your general health and about any side effects you may be having.

On the day before surgery or the day of the surgery itself:

* Your weight will be measured.
* Blood (about 3 tablespoons) will be drawn for routine tests and for research about the safety of metformin-ER and how it may affect the disease. This routine blood draw will include a pregnancy test if you are able to become pregnant.
* You will be asked about your general health and about any side effects you may be having.
* During the surgery, extra tissue samples will be collected for biomarker testing.

Length of Study:

You will be on study for up to 30 days. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have had the surgery.

This is an investigational study. Metformin-ER is FDA approved and commercially available for the treatment of type 2 diabetes. Its use in this study is investigational.

Up to 23 patients will take part in this study. All will be enrolled at MD Anderson.

An Open-Labeled Pilot Study of Biomarker Response Following Short-Term Exposure to Metformin

An Open-Labeled Pilot Study of Biomarker Response in Patients With Colorectal Cancer or Endoscopically Non-Resectable Adenomas Following Short-Term Exposure to Metformin Extended Release (ER)

Primary outcome measure is change in the percentage of Ki67-positive-staining cells between the baseline colonoscopy and surgery in the colon rectal cancer/non-resectable adenoma samples.

M.D. Anderson Cancer Center

Nervous System Diseases

Symptoms and General Pathology

Rare Diseases

Neuralgia

Chronic Pain

Cancer Pain

Pain

Neurologic Manifestations

Peripheral Nervous System Diseases

Neuromuscular Diseases

Chronic Graft Versus Host Disease

Analgesics

Central Nervous System Depressants

Adjuvants, Anesthesia

Analgesics, Opioid

Oxymorphone

Narcotics

Anesthetics

* Study Medication: Oxymorphone ER 5 mg, 10 mg, 20 mg, and 40 mg tablets
* Rescue Medication: Oxymorphone IR 5 mg and 10 mg tablets
* Treatment will consist of up to 12 months of dosing with Oxymorphone ER.

Oxymorphone Extended Release

Study Director

The purpose of this study is to determine if Oxymorphone Extended Release is effective and safe in treating chronic pain in patients with cancer or neuropathic pain.

The purpose of this study is to evaluate the analgesic effectiveness and tolerability of oxymorphone ER in the treatment of cancer or neuropathic pain. Opioid-naïve subjects are gradually titrated from oxymorphone ER 5 mg, every 12 hours (q12h). All other subjects are titrated to a stable dose (defined as pain scores ≥ 4 on BPI Question 5 on 3 of 5 consecutive days while receiving the same total daily dose of study medication including rescue) with tolerable side effects. Subjects could potentially receive therapy for up to 12 months after the first dose of study medication.

Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain

An Open-Label Long Term Effectiveness and Safety Study of Oxymorphone Extended Release Tablets in Patients With Cancer or Neuropathic Pain

Endo Pharmaceuticals

Sr. Director, CR&D

Polyps

Participants receive two tablets of Metformin ER 500 mg once daily for no more than twelve to eighteen months allowing time for at least one follow up colonoscopy. Dose will be reached in a gradual escalation scheme to improve gastrointestinal tolerance. If participants experience side effects during dose escalation regimen, they will be reduced to one tablet of 500 mg daily, and may continue taking 500 mg daily for the duration of the study.

Control group given matched Placebo once daily for no more than twelve to eighteen months allowing time for at least one follow up colonoscopy.

Starting dose: 500 mg by mouth daily for 1 week with weekly increases of 250 mg daily to target dose of 1000 mg daily.

Placebo

William Ross, MD

The goal of this clinical research study is to learn if metformin extended release (ER) can prevent colonic adenomas from becoming cancerous. Metformin ER will be compared to a placebo.

Metformin ER is designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease.

A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Colonic adenomas are considered pre-cancerous, but they may change into colorectal cancer. Patients have a higher risk of developing additional adenomas if adenomas are found at the time of their follow-up colonoscopy.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to either group.

If you are in Group 1, you will receive metformin ER

If you are in Group 2, you will receive a placebo.

Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Drug Administration:

You will take metformin ER/placebo tablets by mouth 1 time a day with food for 12-18 months (usually 12 months but sometimes up to 18 if the doctor thinks it is needed). This will allow time for at least 1 repeat follow-up colonoscopy.

The dose of metformin ER will be increased at Week 2 and again at Week 3. If you have side effects, the dose may be lowered if the doctor thinks it is needed.

Study Visit:

At 3-12 months or 3-18 months after you start taking metformin ER/placebo, you will have another colonoscopy and standard tissue collection for colonic adenoma(s). This tissue will be used for biomarker testing. Blood (about 3 tablespoons) will be drawn for testing on your blood sugar and for biomarker testing. You will need to fast for 8 hours before this test.

Your blood and tissue will also be used for research on the cause of colorectal cancer and biomarker testing.

Length of Treatment:

You may continue taking the study drug for 12 months. However, if your doctor thinks it is needed, a follow-up colonoscopy may be scheduled for you at either 15 or 18 months after enrollment. If this is the case, you will continue taking the drug for up to 18 months. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the study visit.

This is an investigational study. Metformin ER is FDA approved and commercially available for the treatment of type 2 diabetes. Its use to prevent colonic adenomas is investigational.

Up to 128 patients will take part in this study. All will be enrolled at MD Anderson.

Prospective Trial of Metformin - Chemoprevention Role

A Prospective Placebo-control Double-blind Randomized Trial of Metformin in Chemoprevention of Metachronous Colonic Neoplastic Polyps

Primary endpoint defined as change in overall proliferation index between baseline and first return visit, that is, percentage of Ki-67-stained nuclei, in normal rectal mucosa. Tissue samples will be obtained at baseline colonoscopy and subsequent exams for analysis including Ki67, caspase 3, and various biomarkers and immunohistochemicals studies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open-Labeled Pilot Study of Biomarker Response Following Short-Term Exposure to Metformin	NCT01816659	Colorectal Carc...	Metformin ER	18 Years - 75 Years	M.D. Anderson Cancer Center
Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain	NCT00911261	Chronic Pain Neuropathic Pai... Cancer	Oxymorphone Ext...	18 Years -	Endo Pharmaceuticals
Prospective Trial of Metformin - Chemoprevention Role	NCT01550900	Colorectum	Metformin ER Placebo	40 Years - 75 Years	M.D. Anderson Cancer Center
Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain	NCT00911261	Chronic Pain Neuropathic Pai... Cancer	Oxymorphone Ext...	18 Years -	Endo Pharmaceuticals

Spots Global Cancer Trial Database for extended release