CAMPTOSAR Injection should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. CAMPTOSAR can induce both early and late forms of diarrhea that appear to be mediated by different mechanisms. Both forms of diarrhea may be severe. Early diarrhea (occurring during or shortly after infusion of CAMPTOSAR) may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, and intestinal hyperperistalsis that can cause abdominal cramping. Early diarrhea and other cholinergic symptoms may be prevented or ameliorated by atropine (see PRECAUTIONS, General). Late diarrhea (generally occurring more than 24 hours after administration of CAMPTOSAR) can be life threatening since it may be prolonged and may lead to dehydration, electrolyte imbalance, or sepsis. Late diarrhea should be treated promptly with loperamide. Patients with diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated or antibiotic therapy if they develop ileus, fever, or severe neutropenia (see WARNINGS). Administration of CAMPTOSAR should be interrupted and subsequent doses reduced if severe diarrhea occurs (see DOSAGE AND ADMINISTRATION).
Severe myelosuppression may occur (see WARNINGS).
irinotecan hydrochloride injection
CAMPTOSAR Injection (irinotecan hydrochloride injection) is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride was clinically investigated as CPT-11.
CAMPTOSAR Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. CAMPTOSAR is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.
Media Articles Related to Camptosar (Irinotecan)
FDA approves first non-invasive DNA screening test for colorectal cancer
Source: Colorectal Cancer News From Medical News Today [2014.08.13]
The U.S. Food and Drug Administration has approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the...
New Colorectal Cancer Screening Test Approved
Source: MedicineNet Cancer Specialty [2014.08.13]
Title: New Colorectal Cancer Screening Test Approved
Category: Health News
Created: 8/12/2014 12:35:00 PM
Last Editorial Review: 8/13/2014 12:00:00 AM
Flexible sigmoidoscopy screening reduces colorectal cancer incidence and rate of death
Source: Colorectal Cancer News From Medical News Today [2014.08.12]
Among about 100,000 study participants, screening with flexible sigmoidoscopy resulted in a reduced incidence and rate of death of colorectal cancer, compared to no screening, according to a study...
Low uptake of colorectal cancer screening by African Americans revealed in a Veterans Affairs healthcare network
Source: Colorectal Cancer News From Medical News Today [2014.08.08]
According to researchers in California, African Americans' participation in colorectal cancer screening is low and the use of colonoscopy infrequent despite similar access to care across races in a...
Task force recommends genetic testing of tumor for colorectal cancer patients
Source: Colorectal Cancer News From Medical News Today [2014.08.07]
US Multi-Society Task Force releases consensus statement on genetic evaluation and management of lynch syndrome.Of the 143,000 patients diagnosed with colorectal cancer annually in the U.S.
Published Studies Related to Camptosar (Irinotecan)
Single-agent irinotecan or 5-fluorouracil and leucovorin (FOLFIRI) as second-line chemotherapy for advanced colorectal cancer; results of a randomised phase II study (DaVINCI) and meta-analysis. [2011.08]
BACKGROUND: Second-line treatment with irinotecan for advanced or metastatic colorectal cancer prolongs survival. It is uncertain whether irinotecan is better administered with 5-fluorouracil or alone in patients previously treated with a fluoropyrimidine. We compared toxicity (particularly diarrhoea), quality of life, and efficacy of combination chemotherapy and irinotecan in these patients... INTERPRETATION: Combination treatment compared with single-agent irinotecan reduces alopecia and diarrhoea without compromising efficacy on clinical outcomes. Both regimens remain as reasonable treatment options. FUNDING: Research grant (Pfizer). Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Randomized phase II trial of first-line treatment with tailored irinotecan and S-1 therapy versus S-1 monotherapy for advanced or recurrent gastric carcinoma (JFMC31-0301). [2011.07]
The pharmacokinetics of irinotecan vary markedly between individuals. This study sought to compare tailored irinotecan and S-1 therapy with S-1 monotherapy for the treatment of patients with advanced/recurrent gastric cancer...
A phase I study of the chinese herbal medicine PHY906 as a modulator of irinotecan-based chemotherapy in patients with advanced colorectal cancer. [2011.06]
PHY906 is a novel Chinese herbal preparation that has been used in the Orient for over 1800 years to treat a wide range of gastrointestinal side effects including diarrhea, abdominal cramps, vomiting, fever, and headache. Preclinical and clinical studies were conducted to further investigate the biologic and clinical activities of this herbal medicine...
Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. [2011.05.20]
PURPOSE: The addition of cetuximab to irinotecan, fluorouracil, and leucovorin (FOLFIRI) as first-line treatment for metastatic colorectal cancer (mCRC) was shown to reduce the risk of disease progression and increase the chance of response in patients with KRAS wild-type disease. An updated survival analysis, including additional patients analyzed for tumor mutation status, was undertaken... CONCLUSION: The addition of cetuximab to FOLFIRI as first-line therapy improves survival in patients with KRAS wild-type mCRC. BRAF tumor mutation is an indicator of poor prognosis.
Cetuximab plus capecitabine and irinotecan compared with cetuximab plus capecitabine and oxaliplatin as first-line treatment for patients with metastatic colorectal cancer: AIO KRK-0104--a randomized trial of the German AIO CRC study group. [2011.03.10]
PURPOSE: The AIO KRK-0104 randomized phase II trial investigated the efficacy and safety of cetuximab combined with capecitabine and irinotecan (CAPIRI) or capecitabine and oxaliplatin (CAPOX) in the first-line treatment of metastatic colorectal cancer (mCRC)... CONCLUSION: This randomized trial demonstrates that the addition of cetuximab to CAPIRI or CAPOX is effective and safe in first-line treatment of mCRC. In the analyzed regimens, ORR and PFS did not differ according to KRAS gene mutation status.
Clinical Trials Related to Camptosar (Irinotecan)
Ph I SU011248 + Irinotecan in Treatment of Pts w MG [Active, not recruiting]
Primary Objectives To determine maxi tolerated dose & dose limiting toxicity of SU011248 +
Irinotecan in recurrent MG pts not on EIAEDs To characterize safety & tolerability of
SU011248 + Irinotecan among pts w recurrent MG Secondary Objectives To evaluate
pharmacokinetic profile of SU011248 & Irinotecan when co-administered in pts w MG To evaluate
anti-tumor activity of SU011248 + Irinotecan
Ph. I Temo + O6-BG + Irinotecan in Treatment of Pts w Recurrent / Progressive Cerebral Anaplastic Gliomas [Active, not recruiting]
To determine maximum tolerated dose of CPT-11 when administered following Temodar plus
O6-benzylguanine To characterize any toxicity associated w combo of CPT-11 + Temodar plus
O6-BG To observe pts for clinical antitumor response when treated w combo of CPT-11 + Temodar
Ph. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temo [Active, not recruiting]
To determine activity of combo of Irinotecan + Temozolomide To further characterize any
toxicity associated w combo of Irinotecan + Temozolomide
CS-1008 Used With Irinotecan Versus Irinotecan Alone in Subjects With Metastatic Colorectal Carcinoma Who Failed First-line Treatment With Oxaliplatin [Recruiting]
The purpose of this study is to determine the effect of CS-1008 in combination with
irinotecan compared to irinotecan alone on Progression-Free Survival (PFS) in subjects with
metastatic or advanced colorectal cancer (CRC) who have failed oxaliplatin-based first-line
Panitumumab and Irinotecan for Malignant Gliomas [Recruiting]
This is a phase II study of the combination of panitumumab with irinotecan in malignant
glioma patients. The primary objective of the study is to determine the activity of the
combination of panitumumab with irinotecan as measured by 6-month progression-free survival.
Secondary objectives include the following- to determine the safety of panitumumab in
combination with irinotecan in patients with malignant glioma; to determine the effect of
panitumumab in combination with irinotecan on corticosteroid dose for each patient; to
explore any relationship between epidermal growth factor receptor (EGF-R) mutational
analysis and efficacy or toxicity; and, to determine the response rate and overall survival
of recurrent glioblastoma (GBM) patients treated with panitumumab in combination with
The patients will have histologically documented grade 4 malignant gliomas (glioblastoma
multiforme or gliosarcoma) that have failed at least one prior chemotherapy regimen and all
patients will have received radiation therapy. This study will investigate second or greater
line of therapy for recurrent grade 4 malignant glioma. The patient population will include
The patients will undergo a baseline magnetic resonance imaging (MRI) as well as a MRI after
every six-week cycle to determine response and progression. After 16 patients with recurrent
GBM are treated, an interim analysis will be conducted. The most common side effects
associated with panitumumab have been dermatological (skin) problems such as erythema
(redness of the skin), acneiform rash (skin eruptions of the face), skin exfoliation,
pruritus (itching), skin fissures (skin tears), xerosis (dryness of the eye, skin, or
mouth), and rash. The most common side effects associated with irinotecan have been
decreased blood counts of platelets (increased risk of bleeding), white blood cells
(increased risk of infection), red blood cells (anemia); diarrhea, constipation, nausea,
vomiting, tiredness, fever, mouth sores, dehydration (excessive loss of body fluids), rash,
itching, changes in skin color, swelling, numbness, tingling, dizziness, confusion, low
blood pressure, sweating, hot flashes, hair loss, inflammation of the liver, flu-like
symptoms, decreased urine output, shortness of breath, and pneumonia (inflammatory disease
of the lungs).
Reports of Suspected Camptosar (Irinotecan) Side Effects
Disease Progression (33),
Colon Cancer (10),
Pancreatic Carcinoma (5),
Decreased Appetite (4), more >>
Page last updated: 2014-08-13