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Antineoplastic Agents

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Herbal and Botanical

Octreotide

Antineoplastic Agents, Hormonal

Cola

octreotide acetate

J. Cameron Muir, MD

RATIONALE: Palliative therapy with octreotide may help patients who have bowel obstruction that cannot be removed by surgery to live longer and more comfortably.

PURPOSE: Phase II trial to study the effectiveness of octreotide as palliative therapy in treating patients who have cancer-related bowel obstruction that cannot be removed by surgery.

OBJECTIVES:

* Determine the effectiveness of octreotide in the palliation of bowel obstruction secondary to cancer.
* Characterize the dose and tolerability of octreotide in this patient population.

OUTLINE: Patients receive octreotide subcutaneously or IV over 24 hours on days 2-5.

Patients who respond well to study may continue octreotide for palliative effects.

PROJECTED ACCRUAL: A total of 9-25 patients will be accrued for this study over 9 months.

Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery

Octreotide for Palliation of Inoperable Bowel Obstruction: A Phase II Study

National Cancer Institute (NCI)

Northwestern University

Anorexia

Pain

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

nicotine

Placebo

Quality of life

Aminah Jatoi, MD

Gerardo Colon-Otero, MD

RATIONALE: The use of a nicotine inhaler may help decrease appetite and relieve "hunger pain" (an intense craving for food) in patients with malignant bowel obstruction caused by cancer.

PURPOSE: This randomized clinical trial is studying the side effects and how well a nicotine inhaler works in treating "hunger pain" in patients with malignant bowel obstruction caused by cancer.

OBJECTIVES:

* Determine whether patients with malignant bowel obstruction due to incurable cancer utilize a potential therapy for "hunger pain."
* Determine, preliminarily, the efficacy and toxicity of nicotine in treating "hunger pain" in these patients.
* Determine whether nicotine results in a decline in circulating ghrelin (for patients enrolled at the Mayo Rochester Clinic only).
* Evaluate hormonal changes in patients treated with nicotine (for patients enrolled at the Mayo Rochester Clinic only).

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter, pilot study. Patients are stratified according to vomiting status within the past 24 hours (yes vs no) and use of narcotics (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive a nicotine inhaler to use as needed for "hunger pain." Treatment continues for up to 48 hours in the absence of unacceptable toxicity .
* Arm II: Patients receive a placebo inhaler to use as needed for "hunger pain." Treatment continues for up to 48 hours in the absence of unacceptable toxicity.

After 48 hours, patients in arm I may continue nicotine therapy off study. Patients in arm II who are not surgical candidates may cross over to treatment with the nicotine inhaler off study.

Blood and spot urine samples are collected at baseline and after 48 hours from patients enrolled at the Mayo Rochester Clinic. Blood samples are analyzed to evaluate circulating hormone (e.g., ghrelin, leptin) concentrations. Urine samples are analyzed to evaluate nicotine and nicotine metabolite concentrations.

Global quality of life is assessed at baseline and after 48 hours. "Hunger pain" is assessed at baseline.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer

A Pilot Study of Nicotine for "Hunger Pain" in Patients With Bowel Obstruction From Incurable Cancer

Mayo Clinic

Aminah Jatoi, M.D.

Substance Related Disorders

Behaviors and Mental Disorders

Chronic Pain

Opioid-Induced Constipation

Chronic Graft Versus Host Disease

Narcotic Antagonists

Analgesics

Central Nervous System Depressants

Naloxone

Analgesics, Opioid

Narcotics

naloxone hydrochloride

Nathaniel Katz, MD

RATIONALE: Naloxone may be effective in treating constipation that may be caused by opioid pain medications such as morphine.

PURPOSE: Phase III trial to determine the effectiveness of naloxone in relieving constiption in patients who are receiving opioids for chronic pain.

OBJECTIVES: I. Assess the long-term safety and efficacy of oral naloxone in treating opioid-induced constipation in patients with chronic malignant or non-malignant pain.

OUTLINE: This is a multicenter study. Patients receive oral naloxone twice daily. Each patient receives an escalating dose until the minimum effective dose or the maximum dose allowed is reached. The minimum effective dose is defined as the dose at which a patient has at least 4 bowel movements within 7 days. Patients receive the minimum effective dose for 7 days and then continue long-term treatment for a maximum of 72 weeks. Patients receiving the maximum dose allowed with fewer than 4 bowel movements per week will discontinue study therapy.

PROJECTED ACCRUAL: Approximately 600 patients will be accrued for this study.

Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase IIB Study of Oral Naloxone for the Treatment of Opioid-Induced Constipation in Patients With Chronic, Non-malignant Pain or Malignant Pain

Dana-Farber Cancer Institute

Carcinoid Tumor

Syndrome

Malignant Carcinoid Syndrome

Serotonin Syndrome

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Quality of Life

Carcinoid Syndrome

Neuroendocrine Tumor

Neuroepithelioma

bowel obstruction management

quality-of-life assessment

Willis G. Parsons, MD, PC

RATIONALE: The use of endoscopy to place a metal stent in the large intestine is less invasive than surgery for treating cancer-related bowel obstruction and may have fewer side effects and improve recovery.

PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of a metal stent in treating patients who have cancer-related bowel obstruction.

OBJECTIVES:

* Determine the objective response and clinical outcome in patients with colonic obstruction secondary to malignancy treated with enteral Wallstents.
* Evaluate the efficacy and safety of this treatment in these patients.
* Evaluate the quality of life of these patients after enteral Wallstent placement.

OUTLINE: All patient undergo a colonoscopy, followed by placement of an enteral Wallstent through an endoscope under fluoroscopic guidance into the large intestine.

Quality of life is assessed at 48 hours and 6 months after the procedure.

Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction

A Pilot Phase I/II Trial of Enteral Wallstents for Colonic Obstruction in the Setting of Malignancy

Duodenal Obstruction

Duodenal Diseases

RATIONALE: The use of endoscopy to place metal stents in the duodenum is less invasive than surgery for treating cancer-related duodenal obstruction and may have fewer side effects and improve recovery.

PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum.

OBJECTIVES:

* Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents.
* Evaluate the efficacy and safety of this treatment in these patients.
* Evaluate the quality of life of these patients after enteral Wallstent placement.

OUTLINE: Patients undergo enteral Wallstent placement through an endoscope under fluoroscopic guidance into the duodenum.

Quality of life is assessed at 48 hours and 6 months after procedure.

Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction

A Pilot Phase I/II Trial of Enteral Wallstents for Duodenal Obstruction in the Setting of Malignancy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery	NCT00004895	Colorectal Canc... Constipation, I... Extrahepatic Bi... Gastric Cancer Gastrointestina... Nausea and Vomi... Ovarian Cancer Pancreatic Canc... Peritoneal Cavi... Small Intestine...	octreotide acet...	18 Years -	Northwestern University
Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer	NCT00425906	Anorexia Constipation, I... Pain Psychosocial Ef... Unspecified Adu...	nicotine Placebo Quality of life	18 Years - 120 Years	Mayo Clinic
Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery	NCT00004895	Colorectal Canc... Constipation, I... Extrahepatic Bi... Gastric Cancer Gastrointestina... Nausea and Vomi... Ovarian Cancer Pancreatic Canc... Peritoneal Cavi... Small Intestine...	octreotide acet...	18 Years -	Northwestern University
Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer	NCT00425906	Anorexia Constipation, I... Pain Psychosocial Ef... Unspecified Adu...	nicotine Placebo Quality of life	18 Years - 120 Years	Mayo Clinic
Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain	NCT00020605	Constipation, I... Unspecified Adu...	naloxone hydroc...	18 Years - 120 Years	National Cancer Institute (NCI)
Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction	NCT00004911	Colorectal Canc... Constipation, I... Gastric Cancer Gastrointestina... Gastrointestina... Quality of Life Small Intestine...	bowel obstructi... quality-of-life...	18 Years -	Northwestern University
Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction	NCT00004910	Colorectal Canc... Constipation, I... Extrahepatic Bi... Gastric Cancer Gastrointestina... Gastrointestina... Pancreatic Canc... Quality of Life Small Intestine...	bowel obstructi... quality-of-life...	18 Years -	Northwestern University
Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain	NCT00020605	Constipation, I... Unspecified Adu...	naloxone hydroc...	18 Years - 120 Years	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for constipation, impaction, and bowel obstruction