Direct tumor extension into the stomach, duodenum, small bowel or large bowel
Participants may not have current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within months prior to starting study drugs
Patients may not have current signs and/or symptoms of bowel obstruction within month prior to starting study drugs, except if it was a temporary incident (improved within < hours [hr] with medical management)
Tumor is causing symptomatic bowel obstruction (patients who have had a temporary diverting ostomy are eligible)
OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, unresolved bowel obstruction
Symptomatic bowel obstruction within months prior to screening visit
Lesions suspected to be at higher-risk for bleeding such as bowel involvement with tumor that invades into the bowel wall or involves the intraluminal component of bowel by imaging or direct visualization or central pulmonary lesions
Hospitalization for bowel obstruction within months prior to enrollment
No condition that could affect the absorption of study drug, including any of the following:\r\n* Malabsorption syndrome\r\n* Disease significantly affecting gastrointestinal function\r\n* Bowel obstruction or sub-obstruction
a radiographically confirmed bowel obstruction within months prior to the first dose of study drug
Any gastrointestinal condition causing malabsorption or obstruction (e.g. celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
Ongoing bowel perforation or presence of bowel fistula or abscess or history of small or large bowel obstruction within months of registration, including subjects with palliative gastric drainage catheters. Subjects with palliative diverting ileostomy or colostomy are allowed if they have been symptom-free for more than months.
Malignant bowel obstruction
Active bowel obstruction, ileus, or active or remote pancreatitis
History of bowel obstruction within days from proposed start of treatment
Morbidities or concurrent major illness (for example, bowel obstruction or a second active malignancy) that, in the opinion of the treating healthcare provider, would make participation in the trial problematic
History of bowel obstruction within month prior to starting study drugs
No recent (=< months) of partial or complete bowel obstruction unless surgically corrected
Evidence of complete or partial bowel obstruction
Severe constipation or condition where exacerbation of constipation is not advisable (e.g. small bowel obstruction history)
Subjects with bowel obstruction
Hydronephrosis or biliary obstruction
Any signs or symptoms of bowel obstruction within days prior to study entry
For individual baskets: Appendiceal adenocarcinoma: Must not have clinically symptomatic malignant bowel obstruction; Cutaneous squamous cell carcinoma: none; Small bowel adenocarcinoma: must not have clinically symptomatic malignant small bowel obstruction
Patients with known urinary outflow obstruction
Urinary tract obstruction or marked hydronephrosis
Clearance of mTc mercaptoacetyltriglycine (MAG) within . x ULN and no evidence of obstruction on the scan
Unresolved partial or complete small or large bowel obstruction.
Subject with extensive pelvic mass at risk of fistulization, or history of bowel obstruction within months prior to the proposed first dose of study treatment
History of bowel obstruction within month prior to starting study drugs
Direct tumor extension into the stomach, duodenum, small bowel or large bowel
Clinical evidence of bowel obstruction at the time of study entry
Patients with risk factors for bowel obstruction or bowel perforation (e.g., acute diverticulitis) will be excluded
Patients who have a history of a small or large bowel obstruction within weeks of screening or who have and active partial small bowel obstruction or percutaneous endoscopic gastrostomy (PEG)-tube
Small bowel obstruction
Patients with complete bowel obstruction or who are at high risk for gastrointestinal (GI) perforation or severe hemorrhage and patients with inflammatory bowel disease
Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
Clinically significant ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are to be excluded
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nCurrent signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within days before study enrollment
PHASE II COLORECTAL CANCER COHORT (MEDI+C ONLY):\r\nCurrent signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within days before study enrollment
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within months prior to starting study drugs
Tumor-induced symptomatic bowel obstruction
Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
Patients with tumor-caused symptomatic bowel obstruction
The presence of complete or partial bowel obstruction based upon clinical assessment
Poor bowel preparation
No evidence of biliary duct obstruction, unless obstruction is controlled by local treatment or, in whom the biliary tree can be decompressed by endoscopic or percutaneous stenting with subsequent reduction in bilirubin to below . x upper level of normal (ULN)
Patients with evidence of high-grade symptomatic duodenal obstruction
History of prior bowel fistula, ulcerations, or perforations
Unresolved partial or complete small or large bowel obstruction.
Any signs, symptoms, and/or radiographic evidence of a complete or partial bowel obstruction
Clinically significant gastrointestinal (GI) disorders, including history of small bowel obstruction unless the obstruction was a surgically treated remote episode
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within months prior to starting study drugs
Lesions suspected to be at higher-risk for bleeding such as bowel involvement with tumor that invades into the bowel wall or involves the intraluminal component of bowel by imaging or direct visualization or central pulmonary lesions
Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome); unable or unwilling to swallow tablets BID
Imaging evidence of common bile duct obstruction
History of gastrointestinal disease causing malabsorption or obstruction such as, but not limited to Crohns disease, celiac sprue, tropical sprue, bacterial overgrowth/blind loop syndrome, gastric bypass surgery, strictures, adhesions, achalasia, bowel obstruction, or extensive small bowel resection
Known urinary tract obstruction
The participant has bowel obstruction or history of chronic diarrhea that is considered clinically significant.
Patients must not have an acute or subacute intestinal obstruction; no history of bowel obstruction, gastrointestinal (GI) perforation, major abdominal surgery with bowel resection, or perirectal/perianal abscess within months prior to randomization
Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within weeks prior to study entry, uncontrolled diarrhea in the last weeks prior to enrollment, or history of inflammatory bowel disease.
History of bowel obstruction or malabsorption syndromes (within the last months) which might limit the absorption of the study drug
Active bowel obstruction, or hospitalization for bowel obstruction within months prior to screening
Patients must be able to tolerate oral medication and not have evidence of active bowel obstruction\r\n* Note: patients can have a history of prior bowel obstruction, provided the patient is not having symptoms of bowel obstruction at the time of enrolment and the bowel obstruction is not anticipated to recur during the participation in the study
Appendiceal adenocarcinoma basket\r\n* Complete or partial bowel obstruction
History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess; evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction
Has symptoms of bowel obstruction in the past months
Have an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator.
Clinically significant signs and/or symptoms of bowel obstruction within months prior to starting treatment
Participants may not have evidence of a bowel obstruction, abdominal fistula, or intra-abdominal abscess within months of study entry; participants with current signs or symptoms suggestive of bowel obstruction including early or partial obstruction are ineligible; participants with a history of gastrointestinal perforation at any time point are ineligible
The following are additional exclusion criteria for patients enrolling post safety run in:\r\n* Any clinical or radiographic evidence of a partial or complete bowel obstruction (small or large bowel) currently or within the past months\r\n* No current dependency on total parental nutrition (TPN) or within the past days
Has other serious illness or medical condition, such as active infection, unresolved bowel obstruction, psychiatric disorders, or cerebrovascular accident within year of study start
Participant has persistent diarrhea or clinically significant malabsorption syndrome or known sub-acute bowel obstruction ? Grade , despite medical management
Concomitant diseases/conditions: cardiac disease, immunodeficiency, chronic active hepatitis or cirrhosis, uncontrolled infection, bowel obstruction, any other major illness
Participants may not have current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within months prior to starting study drugs
History of bowel obstruction, refractory ascites, or bowel perforation due to advanced disease within the past months from start of study treatment
No evidence of biliary duct obstruction, unless obstruction is controlled by local treatment or, in whom the biliary tree can be decompressed by endoscopic or percutaneous stenting with subsequent reduction in bilirubin to below . x upper level of normal (ULN)
Presence of bowel fistula
No prior GI perforation, or GI obstruction or involvement of the bowel on imaging
History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess; evidence of recto sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction
Anticipation of immediate need for a major surgical procedure (e.g., impending bowel obstruction, gastrointestinal perforation) or radiation therapy during the trial
Hospitalization for bowel obstruction within months prior to enrollment.
Patients with symptoms of partial or complete bowel obstruction and recent (within month) history of fistula, intra-abdominal abscess or bowel perforation
Subjects with evidence of recto?sigmoid involvement by pelvic examination or bowel involvement on\r\ncomputed tomography (CT) scan or clinical symptoms of bowel obstruction
History of small or large bowel obstruction within months of registration, including subjects with palliative gastric drainage catheters; subjects with palliative diverting ileostomy or colostomy are allowed if they have been symptom free for more than months
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within months prior to starting study drugs
Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression
No medical condition that could interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction)
Patients who have required any treatment (medical or surgical) for bowel obstruction prior to diagnosis of bladder cancer or who have required surgical treatment for bowel obstruction after the cystectomy
Have other serious illness or medical condition, such as active infection, unresolved bowel obstruction, psychiatric disorders, or cerebrovascular accident within year of study start
Direct tumor extension into the stomach, duodenum, small bowel or large bowel
Recent history (? months) or ongoing partial or complete bowel obstruction unless due to disease under study and corrected with surgery.
Patients with partial or complete bowel obstruction due to abdominal carcinomatosis
Current bowel obstruction
At a higher than average risk, in the Investigator's opinion, of bowel perforation (e.g., symptoms of partial or complete bowel obstruction, recent (within months) history of fistula or bowel perforation, requirement for total parenteral nutrition and continuous hydration)
Recent (? months) history of partial or complete bowel obstruction.
History of bowel obstruction, including sub-occlusive disease, related to the underlying disease or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscesses. Evidence of rectosigmoid involvement by pelvic examination or bowel involvement on computed tomography (CT) scan or clinical symptoms of bowel obstruction.
Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention
Unresolved diarrhea and bowel obstruction
No acute gastrointestinal conditions, such as: obstruction, fecal impaction, obstipation, acute surgical abdomen, ongoing need for manual maneuvers to induce bowel movements (such as digital evacuation)
Have clinical evidence of current or impending bowel obstruction
Patient has a history of irritable bowel syndrome, signs of active gastrointestinal (GI) bleeding, acute surgical abdomen, bowel stents, indwelling peritoneal catheter, mechanical GI obstruction, fecal impaction, or fecal ostomy
Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within weeks prior to study entry, uncontrolled diarrhea in the last weeks prior to enrollment, or history of inflammatory bowel disease
Clinical evidence of bowel obstruction at the time of study enrollment
Bowel obstruction
Risk for gastric aspiration (ie; ileus, esophageal or bowel obstruction, active vomiting)
Known upper gastrointestinal (UGI) tract obstruction precluding ERC.
Patients with complete or partial bowel obstruction as determined by the palliative care physician
Patients with a bowel ostomy
No cross sectional imaging findings indicative of multi-segmental (> site) small bowel obstruction, or small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity
Evidence of complete or partial bowel obstruction
Patients with bile duct obstruction
Patients with a history of or current bowel obstruction
Opiate-induced uncontrolled constipation or bowel obstruction
Have clinical evidence of lymphedema, current bowel obstruction, or symptomatic brain metastases, as determined by their treating oncologist.
Diagnosis of/problems with chronic diarrhea or history of bowel obstruction or esophageal stricture
Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients.
Irritable bowel syndrome, chronic constipation, functional bowel disorders, or colonic motility disorder
Unresolved bowel obstruction
No evidence of biliary duct obstruction unless obstruction controlled by local treatment or, the biliary tree can be decompressed by endoscopic or percutaneous stenting with subsequent reduction in bilirubin to ?.ULN
Patient must have malignant bowel obstruction (MBO) as evidenced by all of the following:\r\n* Clinical evidence of a small bowel obstruction (via history, physical, and radiographic examination)\r\n* Bowel obstruction below (distal to) ligament of Treitz\r\n* Intra-abdominal primary cancer with incurable disease
Patients must have malignant bowel obstruction due to an intra-abdominal primary cancer (i.e. gastrointestinal [GI], pancreas, ovarian, uterine, cervical, kidney, bladder, prostate, gastrointestinal stromal tumor [GIST] [all sites], and sarcoma); patients may still have primary tumor as long as it is not a primary large bowel obstruction from colorectal cancer
Suspicion or known history of gastrointestinal obstruction