WARNINGS
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).
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CAMPTOSAR SUMMARY
Camptosar®
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.
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NEWS HIGHLIGHTSMedia Articles Related to Camptosar (Irinotecan)
Some Gut Bacteria May Affect Colorectal Cancer Risk
Source: Medscape Gastroenterology Headlines [2013.12.06]
Patients with colorectal cancer have a less diverse gut microbiome; some bacterial taxa are associated with increased cancer risk.
Medscape Medical News
New colorectal cancer target found in stem cell gene
Source: Cancer / Oncology News From Medical News Today [2013.12.02]
Researchers in Canada found that switching off a gene in the cancer stem cells that drive colon cancer stops them from being able to renew themselves. They say their study offers a starting point to treatments that could shut the cancer down.Cancer stem cells are cells that have the ability to differentiate into all the types of cell that exist in that type of tumor.
Risk of hip fracture, colorectal cancer not reduced by calcium plus vitamin D supplementation
Source: Bones / Orthopedics News From Medical News Today [2013.11.20]
New results are in from the Women's Health Initiative (WHI) Calcium plus Vitamin D Supplementation Trial. These findings assess the effects on hip fracture and colorectal cancer incidence among 30,000 postmenopausal women nearly five years after the seven-year period of calcium plus vitamin D supplementation ended.
Initial study results demonstrate detection rate of 75% for colorectal cancer
Source: Clinical Trials / Drug Trials News From Medical News Today [2013.11.11]
VolitionRx Limited (OTC: VNRX), a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, has announced the publication of preliminary data from an ongoing independent trial of one of its NuQ® assays. Priv.-Doz. Dr.
Patients with colorectal cancer liver metastases benefit from nuclear medicine therapy
Source: Liver Disease / Hepatitis News From Medical News Today [2013.11.08]
For patients who fail to respond to current first-line and second-line treatments for colorectal cancer liver metastases (also known as salvage patients), radioembolization with Y-90 microspheres could extend survival according to new research published in the November issue of The Journal of Nuclear Medicine.
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]
Objectives:
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
+ O6-BG
Ph. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temo [Active, not recruiting]
Objective:
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
treatment.
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
irinotecan.
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
32 patients.
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),
Diarrhoea (18),
Death (11),
Colon Cancer (10),
Neutropenia (6),
Hyperkalaemia (5),
Pancreatic Carcinoma (5),
Malaise (5),
Vomiting (5),
Decreased Appetite (4), more >>
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Page last updated: 2013-12-06
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