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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NEWS HIGHLIGHTSMedia Articles Related to Camptosar (Irinotecan)
Poniard Pharmaceuticals Announces Updated Positive Clinical Data From Phase 2 Trial Of Picoplatin In Colorectal Cancer
Source: Colorectal Cancer News From Medical News Today [2009.11.18]
Poniard Pharmaceuticals, Inc. (Nasdaq: PARD) announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC).
'Cross-talk' Mechanism Contributes To Colorectal Cancer
Source: Colorectal Cancer News From Medical News Today [2009.11.14]
Researchers at the University of Wisconsin-Madison School of Medicine and Public Health have identified a molecular mechanism that allows two powerful signaling pathways to interact and begin a process leading to colorectal tumors. "We are very excited about these findings," says Vladimir Spiegelman, an associate professor of dermatology. "Drugs could be developed to block this mechanism and prevent colorectal cancer, which affects millions of people worldwide.
African-Americans With Colorectal Cancer Have Poorer Outcomes, Lower Survival Rates
Source: Colorectal Cancer News From Medical News Today [2009.11.13]
New research published in the November issue of the Journal of the American College of Surgeons shows that African-American patients with colorectal cancer are more likely to be diagnosed with advanced disease and are less likely to undergo surgical procedures compared with Caucasians, suggesting that improvements in screening and rates of operation may reduce differences in colorectal cancer outcomes for African-Americans.
Amgen Announces Overall Survival Results For Vectibix(R) In First-Line Metastatic Colorectal Cancer
Source: Colorectal Cancer News From Medical News Today [2009.11.06]
Amgen (Nasdaq: AMGN) announced that the Phase 3 PRIME "203" trial evaluating Vectibix® (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as a first-line treatment of metastatic colorectal cancer (mCRC) failed to meet a secondary endpoint of overall survival.
Gastrocor(R) Introduces New FISH Test For Colorectal Cancer Detection
Source: Colorectal Cancer News From Medical News Today [2009.11.02]
GastroFISH™ is the first tissue-based fluorescence in situ hybridization (FISH) test for the detection of chromosomal anomalies associated with colon cancer. "We are excited to be the first laboratory to offer GastroFISH for the colon. Using current histological techniques, identifying adenomas with a high risk for progression to cancer is not possible.
Published Studies Related to Camptosar (Irinotecan)
A phase II trial evaluating capecitabine and irinotecan as second line treatment in patients with oesophago-gastric cancer who have progressed on, or within 3 months of platinum-based chemotherapy. [2009.08]
RATIONALE: There is no standard second line therapy for relapsed oesophago-gastric (O-G) cancer... CONCLUSIONS: Capecitabine and irinotecan has anti-tumour activity as second line treatment for relapsed O-G cancer, and provides an important improvement in disease related symptoms.
A multicenter randomized phase II study of the irinotecan/gemcitabine doublet versus irinotecan monotherapy in previously treated patients with extensive stage small-cell lung cancer. [2009.08]
CONCLUSIONS: Although the IG regimen seems to be more active than the I monotherapy, the premature closure of the study prevents the drawing of definitive conclusions.
Randomized phase III trial comparing biweekly infusional fluorouracil/leucovorin alone or with irinotecan in the adjuvant treatment of stage III colon cancer: PETACC-3. [2009.07.01]
PURPOSE The primary objective of this randomized, multicenter, phase III trial was to investigate whether the addition of irinotecan to the de Gramont infusional fluorouracil (FU)/leucovorin (LV) adjuvant regimen (LV5FU2) would improve disease-free survival (DFS) in patients with stage III colon cancer...
Comparing safety and efficacy of first-line irinotecan/fluoropyrimidine combinations in elderly versus nonelderly patients with metastatic colorectal cancer: findings from the bolus, infusional, or capecitabine with camptostar-celecoxib study. [2009.06.15]
BACKGROUND: Irinotecan-based chemotherapy regimens are 1 option for treatment of metastatic colorectal cancer (mCRC). The authors report the safety and efficacy of such regimens in elderly patients using a large phase III trial (bolus, infusional, or capecitabine with camptostar-celecoxib [BICC-C]) cohort... CONCLUSIONS: Irinotecan/fluoropyrimidine combinations are well tolerated in the elderly population, with similar efficacy to that found in nonelderly patients in first-line mCRC. (c) 2009 American Cancer Society.
Phase III noninferiority trial comparing irinotecan with oxaliplatin, fluorouracil, and leucovorin in patients with advanced colorectal carcinoma previously treated with fluorouracil: N9841. [2009.06.10]
PURPOSE: The primary goal of this multicenter phase III trial was to determine whether overall survival (OS) of fluorouracil (FU) -refractory patients was noninferior when treated with second-line infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4; arm B) versus irinotecan (arm A). Cross-over to the other treatment on disease progression was mandated... CONCLUSION: In patients who experienced treatment failure with front-line FU therapy, OS does not significantly differ whether second-line therapy begins with irinotecan or FOLFOX4. FOLFOX4 produces higher RR and longer TTP. Both arms had notable OS in patients who experienced treatment failure with first-line FU therapy.
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
CAmpto-CISplatine Plus Radiotherapy in Advanced Cervix Cancer : Search of Tolerated Maximum Dose of Campto [Completed]
Search of maximum tolerated irinotecan dose in association with cisplatin and pelvic
radiotherapy in patients with an advanced cervix cancer.
Taxotere, Cisplatin and Irinotecan (CPT-11) for Esophagogastric Cancer [Active, not recruiting]
This is a phase II study of taxotere, cisplatin and irinotecan (CPT-11) used in combination
to treat metastatic esophageal and gastric cancer in an effort to see what effects (good and
bad) the combination may have on the patients cancer.
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