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regimen-monograph
CRBPGEMCPACL
A - Regimen Name
CRBPGEMCPACL Regimen
Carboplatin-Gemcitabine-Paclitaxel
Disease Site
Unknown Primary
Intent
Palliative
Regimen Category
Local : A regimen not widely used by Regional Cancer Centres in this disease site.
Rationale and Uses
For the treatment of metastatic cancer of unknown primary, including well-differentiated adenocarcinoma, poorly differentiated adenocarcinoma, poorly differentiated carcinoma, and squamous cell carcinoma. Only data from single arm trials are available.
B - Drug Regimen
| PACLitaxel
(Round to nearest 3 mg) |
200 mg /m² | IV | Day 1 |
| CARBOplatin | AUC = 5 | IV | Day 1 |
| gemcitabine | 1000 mg /m² | IV | Days 1 and 8 |
|
For patients who respond or have stable disease after 4 cycles, give: |
|||
| PACLitaxel
(Round to nearest 3 mg) |
70 mg /m² | IV | Days 1, 8, 15, 22, 29, 36 |
C - Cycle Frequency
REPEAT EVERY 21 DAYS
For up to 4 cycles, unless disease progression or unacceptable toxicity.
Then, if patient responds or has stable disease, give paclitaxel ONLY and
REPEAT EVERY 56 DAYS
(6 weeks on, 2 weeks off) for 3 cycles, unless disease progression or unacceptable toxicity
D - Premedication and Supportive Measures
Antiemetic Regimen:
Moderate (Day 1)
Low (Day 8)
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 or 20mg IV 30 minutes before paclitaxel (or 10mg IV 30 minutes before weekly low dose paclitaxel).
- DIPHENHYDRAMINE 50mg IV 30 minutes before paclitaxel
- RANITIDINE 50mg IV 30 minutes before paclitaxel
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 could be considered.
Dosage with toxicity
Day 1: CRBPGEMCPACL
Worst Toxicity / Counts (x 109/L) in previous cycle |
|
Worst Toxicity / Counts (x 109/L) in previous cycle |
PACLitaxel (% previous dose) |
CARBOplatin (% previous dose) |
gemcitabine (% previous dose) |
||
ANC <1.5 |
Or |
Platelet < 75 |
Hold until platelets ≥ 100 and ANC ≥ 1.5 |
||||
Febrile Neutropenia Or ANC < 0.5 for ≥ 5-7 d |
Or |
Thrombocytopenic bleeding Or Platelets < 25 |
Hold *, then 75% |
||||
| Grade 3 or 4 neuropathy | Discontinue | ||||||
Grade 3 related organ / non-hematologic |
|
|
*75% for suspect drug(s) |
||||
| Grade 4 related organ / non-hematologic, Pneumonitis, Hemolytic-uremic Syndrome (HUS), Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN), Capillary Leak Syndrome (CLS) |
|
|
Discontinue
|
||||
*Do not start new cycle until toxicities have recovered to ≤ grade 2, platelets ≥ 75 x 109/L ( ≥ 100 x 109/L if was held previous week), and ANC ≥ 1.5 x 109/L (or indicated in table above).
Day 8: Gemcitabine
Toxicity on Day 8 of cycle |
Gemcitabine |
||||
Non-hematologic |
|
Hematologic |
% Full Dose |
||
AGC (x 106/L) |
|
Platelets (x 106/L) |
|||
≤ grade 2 |
and |
> 1000 |
and |
> 75,000 |
100% |
Grade 3 or 4 or Febrile neutropenia |
or |
< 1000 |
or |
< 75,000 |
Omit, then 75% for subsequent doses |
Pneumonitis |
|
- |
|
- |
Discontinue |
Weekly Paclitaxel:
| Toxicity / counts (x 109/L) on treatment day | Toxicity / counts (x 109/L) on treatment day | Paclitaxel dose | |
| ANC ≥ 1 | and | Platelets ≥ 75 | 100% |
| ANC < 1 | or | Platelets < 75 | Omit** |
Grade 3 or 4 neurotoxicity |
Discontinue | ||
| Grade 3 related organ/ non-hematologic or febrile neutropenia | Omit**, then 75% for subsequent doses | ||
| Grade 4 related organ / non-hematologic | Discontinue |
**Do not give treatment until toxicities have recovered to ≤ grade 1, platelets ≥ 75 x 109/L, and ANC ≥ 1x 109/L.
Paclitaxel - Dosage after Hypersensitivity:
- For mild symptoms (e.g., mild flushing, rash, pruritus) it is possible to complete the infusion under close supervision.
- For moderate symptoms (e.g., moderate rash, flushing, mild dyspnea, chest discomfort, mild hypotension),
- Stop the paclitaxel infusion and give diphenhydramine 25-50 mg IV and methylprednisolone 125 mg IV.
- Once symptoms have resolved, resume paclitaxel infusion at a rate of 10% of original rate for 15 minutes, then at 25% of original rate for 15 minutes, and if no further symptoms develop, continue at original rate until infusion is complete.
- For severe symptoms (e.g., one or more of: respiratory distress requiring treatment, generalized urticaria, angioedema, hypotension requiring therapy),
- Stop the paclitaxel infusion; give diphenhydramine and methylprednisolone as above. Use epinephrine or bronchodilators if indicated.
- Do not rechallenge with paclitaxel.
Hepatic Impairment
| Bilirubin and/or AST/ALT | Paclitaxel Dose (mg/m2) | CARBOplatin (% previous dose) | gemcitabine (% previous dose) |
| 2-4 x ULN | 135 | No adjustment required | Caution in patients with hepatic impairment (cirrhosis, hepatitis, metastases, etc.). Initial dose reduction should be considered if the patient is treated, especially in hyperbilirubinemia. |
| >4 x ULN | 50 or omit | No adjustment required | Caution or Omit |
Renal Impairment
Creatinine Clearance (mL/min) |
PACLitaxel (% previous dose) |
CARBOplatin (% previous dose) |
gemcitabine (% previous dose) |
>50 |
No adjustment required |
No adjustment required |
No adjustment required |
20-50 |
No adjustment required |
Use Calvert or Chatelut formula |
Caution; monitor for hemolytic uremic syndrome |
<20 |
Caution or omit |
Discontinue |
Caution; monitor for hemolytic uremic syndrome |
F - Adverse Effects
Refer to PACLitaxel, CARBOplatin, gemcitabine drug monograph(s) for additional details of adverse effects
| Most Common Side Effects | Less Common Side Effects, but may be |
|
|
G - Interactions
Refer to PACLitaxel, CARBOplatin, gemcitabine drug monograph(s) for additional details
I - Recommended Clinical Monitoring
Recommended Clinical Monitoring
- CBC; at each visit
- Clinical assessment of fever, infection, musculoskeletal, neurotoxicity, ototoxicity, flu-like symptoms, fatigue, pulmonary toxicity, rash, hypersensitivity, nausea/vomiting
- Liver function tests; baseline and regular
- Renal function tests; baseline and regular, including electrolytes
- Cardiac monitoring with prior arrhythmia
- Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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J - Administrative Information
Approximate Patient Visit
Day 1: 5 hours; Day 8: 0.75 hour
Pharmacy Workload (average time per visit)
32.8 minutes
Nursing Workload (average time per visit)
48.25 minutes
K - References
Greco FA, Burris HA 3rd, Litchy S, et al. Gemcitabine, carboplatin, and paclitaxel for patients with carcinoma of unknown primary site: a Minnie Pearl Cancer Research Network study. J Clin Oncol 2002;20(6):1651-6.
October 2017 Modified dose modifications and monitoring sections
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.
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Last Updated: July 27, 2026
