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Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.

A - Regimen Name

CISPPACL(IP) Regimen
PACLitaxel-CISplatin (intraperitoneal)


Disease Site
Gynecologic - Ovary

Intent
Adjuvant

Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.


Rationale and Uses

Post-operative regimen for patients with stage III optimally debulked (≤1 cm residual disease) epithelial ovarian cancer, primary peritoneal, or fallopian tube carcinoma, who did not receive neoadjuvant chemotherapy

 
B - Drug Regimen

PACLitaxel
135 mg /m² IV Day 1
CISplatin
75 to 100 mg /m² Intraperitoneal Day 1
PACLitaxel
60 mg /m² Intraperitoneal Day 8
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C - Cycle Frequency

REPEAT EVERY 21 DAYS

For a usual total of 6 cycles unless disease progression or unacceptable toxicity occurs

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

High (D1)
Low (D8)


Febrile Neutropenia Risk:

Low

Other Supportive Care:

  • Paclitaxel: Patients Should be Pretreated with a Corticosteroid as well as an antihistamine and a H2 Blocker. For example:
  • DEXAMETHASONE* 20mg PO 12 & 6 hours before Paclitaxel OR 20 mg IV 30 minutes before Paclitaxel
  • DIPHENHYDRAMINE 50mg IV 30 minutes before Paclitaxel
  • RANITIDINE 50mg IV 30 minutes before Paclitaxel
  • Oral hydration is strongly encouraged; poorly hydrated patients may need more IV hydration

Also refer to CCO Antiemetic Recommendations.

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and may be considered.

 

Dosage with toxicity

Hematologic Toxicities

Refer to Appendix 6 for general recommendations.

Neurotoxicity Grade 3 or 4*REDUCE Paclitaxel to 80% dose

* Dose of Cisplatin was reduced with grade 2 peripheral neuropathy in the pivotal trial. (Armstrong et al. NEJM 354:34-43, 2006)



Hepatic Impairment

Bilirubin
Dose
1. If Bilirubin 2-4 x ULN
Give MAXIMUM DOSE of Paclitaxel of 135mg/m2
2. If Bilirubin > 4 x ULN
OMIT Paclitaxel dose or
Give MAXIMUM DOSE of Paclitaxel 50mg/m2

Renal Impairment

 

Creatinine Clearance or Serum Creatinine
Dose
1. If CrCl = 0.5-1.0mL/sec or                                 Serum Creatinine=136-185µmol/L
REDUCE Cisplatin* to 50% dose
2. If CrCl < 0.5mL/sec or
     Serum Creatinine>185µmol/L
OMIT Cisplatin* dose

*Upon the discretion of the prescriber, less dose reduction may be suggested. See Cisplatin drug monograph


 
F - Adverse Effects

Refer to PACLitaxel, CISplatin drug monograph(s) for additional details of adverse effects

 

 


Most Common Side Effects 

Less Common Side Effects, but may be
Severe or Life-Threatening

  • Nausea, vomiting
  • Alopecia
  • Neuropathy (may be severe)
  • Musculoskeletal pain
  • Nephrotoxicity (may be severe)
  • Hearing impaired
  • Myelosuppression +/- infection, bleeding
  • Diarrhea
  • Increased LFTs
  • Mucositis
  • Fatigue
  • Abnormal electrolytes
  • ECG changes
  • Hypersensitivity
  • Arterial thromboembolism
  • Venous thromboembolism
  • GI obstruction/perforation
  • Hemolytic uremic syndrome
  • Pancreatitis
  • Pnuemonitis
  • Vasculitis
  • Cystoid macular edema
 
G - Interactions

Refer to PACLitaxel, CISplatin drug monograph(s) for additional details

 
H - Drug Administration and Special Precautions

Refer to PACLitaxel, CISplatin drug monograph(s) for additional details

 

 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • Clinical toxicity (including local toxicity, neurotoxicity, ototoxicity, abdominal pain) assessment; at each visit
  • CBC; baseline and before each cycle. Interim counts should be done in first cycle and repeated if dose modifications necessary.
  • Baseline and regular liver and renal function (including electrolytes and magnesium) tests.
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information

Approximate Patient Visit
7 to 8 hours
Pharmacy Workload (average time per visit)
44.749 minutes
Nursing Workload (average time per visit)
106.5 minutes
 
K - References

Armstrong DK, Bundy B, Wenzel L, et al: Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med 354:34-43, 2006

Cisplatin and paclitaxel drug monographs, Cancer Care Ontario.

Markham M, Walker J. Intraperitoneal Chemotherapy of Ovarian Cancer: A Review, With a Focus on Practical Aspects of Treatment. JCO 24( 6): February 20th, 2006 (Early Publication).

Markman M, Bundy BN, Alberts DS, et al: Phase III trial of standard-dose intravenous cisplatinplus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: An intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group. J Clin Oncol 19:1001-1007, 2001

August 2021 Modified Rationale and Uses section


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.