WARNING: DIARRHEA AND MYELOSUPPRESSION
Early and late forms of diarrhea can occur. Early diarrhea may be accompanied by cholinergic symptoms which may be prevented or ameliorated by atropine. Late diarrhea can be life threatening and should be treated promptly with loperamide. Monitor patients with diarrhea and give fluid and electrolytes as needed. Institute antibiotic therapy if patients develop ileus, fever, or severe neutropenia. Interrupt CAMPTOSAR and reduce subsequent doses if severe diarrhea occurs.
Severe myelosuppression may occur.
CAMPTOSAR Injection (irinotecan hydrochloride injection) is an antineoplastic agent of the topoisomerase I inhibitor class.
CAMPTOSAR is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol, NF, and 0.9 mg of lactic acid, USP. The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. CAMPTOSAR is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP.
- CAMPTOSAR Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.
- CAMPTOSAR is 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)
No Increased Risk of Colorectal Cancer in Older-Onset IBD
Source: Medscape Allergy & Clinical Immunology Headlines [2016.08.18]
A new diagnosis of inflammatory bowel disease (IBD) in individuals over age 60 does not increase the risk of developing colorectal cancer, although patients may be at increased risk for hematological cancers, say researchers based in France.
Reuters Health Information
Genetic cause of 15 percent of colorectal cancer diagnoses identified
Source: Colorectal Cancer News From Medical News Today [2016.07.20]
Findings open up 'precision medicine' approach to prevention, diagnosis and treatment.
Internal radiation therapy: Better response in metastatic colorectal cancer patients
Source: Colorectal Cancer News From Medical News Today [2016.07.10]
New analysis shows patients with metastatic colorectal cancer treated with radiation therapy show better response than those receiving chemotherapy alone.
Colorectal cancer: Pivotal Phase III data for Xilonix presented
Source: Clinical Trials / Drug Trials News From Medical News Today [2016.07.05]
XBiotech Inc., developer of next-generation True Human™ antibody therapies, has presented positive results from a pivotal Phase III trial of Xilonix™, the company's lead monoclonal...
Anti-PD-L1 immunotherapy shows response in microsatellite-stable metastatic colorectal cancer in combination with MEK inhibition
Source: Colorectal Cancer News From Medical News Today [2016.07.04]
Anti-PD-L1 immunotherapy may achieve a response in patients with microsatellite-stable metastatic colorectal cancer if combined with a MEK inhibitor, according to phase I data presented at the ESMO...
Published Studies Related to Camptosar (Irinotecan)
A phase II, randomized, double blind trial of calcium aluminosilicate clay versus
placebo for the prevention of diarrhea in patients with metastatic colorectal
cancer treated with irinotecan. 
use for metastatic colorectal cancer (CRC) by adsorbing the SN-38 metabolite... CONCLUSION: Compared to placebo, CASAD use was safe but ineffective in preventing
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.
Clinical Trials Related to Camptosar (Irinotecan)
Irinotecan (Camptosar) in Patients With Advanced Sarcomas [Completed]
1. To determine the efficacy of the topoisomerase I (topo I) inhibitor irinotecan,
delivered via a low-dose protracted schedule to patients with advanced sarcoma.
2. To determine the toxicity profile of irinotecan, using a protracted schedule, in this
pretreated patient population.
Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas [Terminated]
Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered
at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine.
At each cycle, patient exams and interviews as well as lab results were to help the research
team to determine the symptomatic side effects of the treatment. Recorded past toxicities
were to be compared with current side effects.
Panitumumab and Irinotecan for Malignant Gliomas [Terminated]
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).
Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas [Terminated]
To determine the maximum tolerated dose (MTD) and toxicity profile of combination
temsirolimus and irinotecan both administered intravenously on a weekly basis.
To determine antitumor activity of this combination of drugs in refractory soft tissue
Talazoparib Plus Irinotecan With or Without Temozolomide in Children With Refractory or Recurrent Solid Malignancies [Recruiting]
The drug, talazoparib, seems to work against cancer in test tubes and animals by preventing
DNA repair in damaged cells leading to their death. Investigators do not know if
talazoparib combined with irinotecan will work in humans. Talazoparib has been used in only
a small number of adults and children, and there is much not yet known about it.
In Arm A of this study, investigators seek to find the safest dose of irinotecan to give
with talazoparib to children and young adults. In a phase I study, different dose levels of
drug may be tested. The first 2 or 3 patients will be given a dose, and if none of them has
a bad side-effect, the next 2 or 3 patients will be given a higher dose. No temozolomide
will be given in in Arm A.
The experimental drug combination of talazoparib and irinotecan will be tested in the hopes
of finding a treatment that may be effective against recurrent or refractory solid tumors.
The goals of study Arm A are:
- To determine whether the combination of talazoparib and irinotecan is a beneficial
treatment for your cancer;
- To learn what kind of side effects talazoparib can cause;
- To learn what kind of side effects talazoparib in combination with irinotecan can
- To learn more about the biology of talazoparib in children diagnosed with solid tumors.
The purpose of Arm B is to to find the safest doses of irinotecan and temozolomide to give
with talazoparib to children and young adults with a solid malignancy.. Talazoparib belongs
to a family of drugs called "poly ADP ribose polymerase or PARP inhibitors." Irinotecan and
temozolomide belong to a family of drugs called "DNA damaging agents."
There are two arms of this trial, A and B. In this study, investigators hope that irinotecan
(administered in Arm A) and irinotecan plus temozolomide (administered in Arm B) will damage
the DNA of the cancer cells. Then, talazoparib (which is a PARP inhibitor) will block the
repair of the cancer cell's damaged DNA, causing the cancer cell to die (a process called
There are different types of cancers found in children and young adults which appear to be
vulnerable to the combination of chemotherapy agents that will be given in this study. Work
carried out in the lab show that these agents may be very promising in the treatment of
ewing sarcoma, germ cell tumors, wilms tumor, medulloblastoma and possibly neuroblastoma.
Reports of Suspected Camptosar (Irinotecan) Side Effects
Disease Progression (33),
Colon Cancer (10),
Pancreatic Carcinoma (5),
Decreased Appetite (4), more >>
Page last updated: 2016-08-18