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Monoclonal Antibodies

bevacizumab for Adenocarcinoma of the Rectum

Phase 2

Waitlist Available

Led By Afsaneh Barzi

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat rectal cancer. The drugs work in different ways to stop the growth of cancer cells. The combination may be effective in treating rectal cancer.

Eligible Conditions

Adenocarcinoma of the Rectum
Rectal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of CPR in the pathology specimen

Secondary outcome measures

Incidence and nature of AEs of special interest for bevacizumab (grades) according to NCI CTCAE v4.0

Incidence and nature of adverse events (AEs) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 ( v4)

Incidence and nature of serious AEs (SAEs) according to NCI CTCAE v4.0

+2 more

Side effects data

From 2017 Phase 1 & 2 trial • 96 Patients • NCT01266031

100%

Headache

100%

Fatigue

83%

Lymphocyte count decreased

83%

Hemoglobin Increase

83%

Nausea

83%

Platelet count decreased

67%

Memory impairment

67%

Bicarbonate Serum-low

67%

Constipation

67%

Dizziness

67%

Gait disturbance

67%

Pyramidal Tract Dysfunction

50%

Hypoalbuminemia

50%

Hyponatremia

50%

Infection with Normal ANC (Neck NOS), (Urinary Tract NOS)

50%

METABOLIC/LABORATORY (elevated LDH)

50%

Edema limbs

50%

Leukocytosis

50%

METABOLIC/LABORATORY (Elevated BUN)

50%

Mood Alteration

50%

Speech Impairment

33%

Neuropathy, Sensory Legs/Toes tingling

33%

Neuropathy, Cranial (Pupil, Upper eyelid)

33%

Aspartate aminotransferase (AST) increased

33%

Taste Alteration

33%

Stomach pain

33%

Diplopia

33%

Muscle weakness- Whole body/generalized

33%

OCULAR/VISUAL (Right & Left visual field deficits)

33%

Hypokalemia

33%

Hypophosphatemia

33%

Alanine aminotransferase (ALT) increased

33%

Alkaline phosphatase increased

33%

Anorexia

33%

Bruising

33%

Confusion

33%

Diarrhea

33%

Gait/walking (wide based ataxic hemiparetic)

33%

Hyperglycemia

33%

Hypoglycemia

33%

METABOLIC/LABORATORY (low creatinine)

33%

METABOLIC/LABORATORY (low protein)

33%

Muscle weakness lower extremity

33%

Seizure

33%

Somnolence

17%

Dehydration

17%

DECUBITUS Ulcer Sacrum

17%

Hyperuricemia

17%

Allergic rhinitis

17%

Bloating

17%

Irregular Menses

17%

Pain (Neuropathic in perineal/buttock)

17%

Heartburn

17%

Hypocalcemia

17%

Mental Status Altered

17%

Infection with Normal ANC (Neck NOS), cellulitis

17%

METABOLIC/LABORATORY (low chloride)

17%

Mucositis oral

17%

Obstruction GI (STOMACH-small bowel nos)

17%

Epistaxis

17%

Tremor

17%

Blood bilirubin increased

17%

Blurred vision

17%

Cholesterol high

17%

Creatinine increased

17%

Cushingoid

17%

Bump at sutura site

17%

Multiple scabs

17%

Dysphagia

17%

Edema cerebral

17%

Gait/walking Impaired mobility

17%

Gastrointestinal (sensitivity to smell)

17%

Hiccups

17%

Infection with Normal ANC (Wound), Herpes Z-back-perineal-scrutum

17%

Joint Pain

17%

METABOLIC/LABORATORY (high chloride)

17%

METABOLIC/LABORATORY (low uric acid)

17%

OCULAR SURFACE DISEASE

17%

OCULAR/VISUAL (Right homonymous hemianopsia)

17%

PAIN (BACK)

17%

Pain in extremity

17%

Pruritus

17%

Sinus bradycardia

17%

Voice alteration

17%

Weight loss

17%

Sensory loss left side

17%

Dyspnea

17%

Vomiting

17%

Hypertriglycedidemia

17%

Infection with Normal ANC (Neck NOS), herpes zoster

17%

Insomnia

17%

Neuropathy, Numbness, Right sided

17%

Sore throat

17%

Urinary tract infection

17%

Hyperpigmentation (hands & knuckles)

100%

80%

60%

40%

20%

Study treatment Arm

Phase I: Vorinostat + Bevacizumab

Phase II: Bevacizumab

Phase II: Bevacizumab + Vorinostat 400 mg

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (bevacizumab, mFOLFOX7)Experimental Treatment5 Interventions

Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxaliplatin

FDA approved

Bevacizumab

FDA approved

Fluorouracil

FDA approved

Leucovorin

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

906 Previous Clinical Trials

1,596,271 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,255 Total Patients Enrolled

20 Trials studying Adenocarcinoma of the Rectum

14,403 Patients Enrolled for Adenocarcinoma of the Rectum

Afsaneh BarziPrincipal InvestigatorUniversity of Southern California

1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are authorized to be involved in this research trial?

"As this trial was last updated on August 5th 2022, recruitment for candidates is no longer taking place. However, there are 1,052 studies actively enrolling patients with cystadenocarcinoma and 820 trials recruiting bevacizumab participants simultaneously."

Answered by AI

To what clinical conditions is bevacizumab typically administered?

"Bevacizumab can be used to combat recurrent platinum sensitive primary peritoneal cancer, rectal carcinoma, and other malignant neoplasms."

Answered by AI

Are there any preceding studies involving bevacizumab?

"Currently, 820 clinical trials involving bevacizumab are in progress with 253 of them operating at the Phase 3 level. These studies are dispersed among an expansive 37297 locations, most notably Guangzhou and other cities within Guangdong Province."

Answered by AI

Is recruitment for this research endeavor still ongoing?

"At present, this trial is not accepting participants. Initiated on August 2nd 2013 and updated five years later in 2022, it appears to have reached its recruitment limit. However, there are 1052 other studies actively recruiting for cystadenocarcinoma patients and an additional 820 trials for bevacizumab that accept new applicants."

Answered by AI