BC Cancer Protocol for Primary Treatment of Advanced/Recurrent
Non-Small Cell Cancer of the Cervix with CARBOplatin and DOCEtaxel
in Ambulatory Care Settings
Protocol Code GOCXCAD
Tumour Group Gynecology
Contact Physician Dr. Jenny Ko
Contact Pharmacist Winnie Cheng
ELIGIBILITY:
non-small cell cancer of the cervix, vulva, or vagina (squamous, adenocarcinoma or mixed)
recurrent or IIIb, IVa or IVb
ineligible for GOCXCRT
Note: The GOCXCAT and GOCXCAD regimens are alternatives. The clinician’s selection should be
based upon the patient’s circumstances. The DOCEtaxel-containing combination produces more
neutropenic complications, diarrhea, edema and hypersensitivity; the PACLitaxel-containing
combination produces more peripheral neurotoxicity, arthralgia, myalgia, and alopecia.1 Physician
may choose between PACLitaxel (GOCXCAT) and DOCEtaxel (GOCXCAD). A maximum of 6
cycles* of taxane treatment will be reimbursed for each line of therapy. However, a patient who had
previously responded to 6 cycles* of say, a PACLitaxel-based regimen may be retreated with another
6 cycles* of a taxane-based regimen.
* may extend to 9 cycles if the patient has not achieved a complete response but is continuing to improve.
EXCLUSIONS:
any small cell component
creatinine greater than 150 micromol/L
neutrophils less than 1 x 109/L
ECOG performance status greater than 2
TESTS:
Baseline: CBC & diff, platelets, creatinine, tumor marker (CA 125, CA 15-3, CA 19-9), ALT, Alk Phos,
bilirubin, GGT, chest X-ray, abdominopelvic imaging, camera nuclear renogram for GFR (if available)
Day 7 and 14 after first cycle (and in subsequent cycle if dose modification made): CBC & diff; once
nadir pattern established, check CBC & diff at that point only
Before each treatment: CBC & diff, creatinine, any initially elevated tumor marker
If clinically indicated: bilirubin, ALT, Alk Phos, LDH, GGT, albumin, protein level
PREMEDICATIONS:
dexamethasone 8 mg PO BID for 3 days, starting one day prior to each DOCEtaxel administration;
patient must receive minimum of three doses pre-treatment
Antiemetic protocol for highly emetogenic chemotherapy protocols (see SCNAUSEA)
DOCEtaxel-induced onycholysis and cutaneous toxicity of the hands may be prevented by wearing frozen
gloves starting 15 minutes before DOCEtaxel infusion until 15 minutes after end of DOCEtaxel infusion;
gloves should be changed after 45 minutes of wearing to ensure they remain cold during the entire
DOCEtaxel infusion.
BC Cancer Protocol Summary GOCXCAD Page 1 of 4
Activated: 1 Aug 2003 Revised: 1 Jun 2022 (antiemetics revised)
Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to
apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at
your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/legal.htm
TREATMENT (give DOCEtaxel first):
Drug Starting Dose BC Cancer Administration Guideline
DOCEtaxel 75 mg/m2 * IV in 250 to 500 mL NS or D5W over 1 hour
(see Precaution #2)
Use non-DEHP equipment.
CARBOplatin Dose = AUC** x (GFR +25) IV in 100 to 250 mL NS over 30 minutes
* Use 60 mg/m2 if patient has a history of neutropenic complications following chemotherapy or prior
extended field radiotherapy. In patients greater than 75 years of age, begin at 60 mg/m2, with
subsequent escalation to 75 mg/m2 if tolerated.
** use AUC of 5. If patient has received extensive prior radiation therapy, use AUC of 4
Measured GFR (e.g. nuclear renogram) is preferred whenever feasible, particularly in circumstances of
co-morbidity that could affect renal function (third-space fluid accumulations, hypoproteinemia, potentially
inadequate fluid intake, etc.). The lab reported GFR (MDRD formula) may be used as an alternative to the
Cockcroft-Gault estimate of GFR; the estimated GFR reported by the lab or calculated using the
Cockcroft-Gault equation should be capped at 125 mL/min when it is used to calculate the initial
CARBOplatin dose. When a nuclear renogram is available, this clearance would take precedence.
Cockcroft-Gault Formula
GFR = 1.04 x (140 - age in years) x wt (kg)
serum creatinine (micromol/L)
Note: The same method of estimation should be used throughout the treatment course (i.e. if lab
reported GFR was used initially, this should be used for dosing in all subsequent cycles and not the
Cockcroft-Gault estimate).
Repeat every 21 days* up to a maximum of 6 cycles (may extend to 9 cycles if the patient has not
achieved a complete response but is continuing to respond.)
.
*If a delay due to hematologic recovery has occurred, extend all future cycles to 28 day intervals.
DOSE MODIFICATIONS:
1. Hematology:
a) on treatment day if patient has never had neutropenic sepsis on DOCEtaxel:
ANC (x 109/L) Platelets (x 109/L) Doses (both drugs)
greater than or and greater than or equal treat as per nadir
equal to 1.5 to 100
1.0 to less than 1.5 and greater than or equal DOCEtaxel 60 mg/m2; CARBOplatin per nadir
to 100 counts
less than 1.0 or less than 100 delay until recovery
BC Cancer Protocol Summary GOCXCAD Page 2 of 4
Activated: 1 Aug 2003 Revised: 1 Jun 2022 (antiemetics revised)
Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to
apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at
your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/legal.htm
b) on treatment day if patient has had neutropenic sepsis on DOCEtaxel:
ANC (x 109/L) Platelets (x 109/L) Doses
greater than or and greater than or equal DOCEtaxel 60 mg/m2; CARBOplatin per nadir
equal to 1.5 to 100 counts
1.0 to less than 1.5 and greater than or equal DOCEtaxel 60 mg/m2; CARBOplatin per nadir
to 100 counts
less than 1.0 or less than 100 delay until recovery
c) at nadir:
ANC (x 109/L) Platelets (x 109/L) DOCEtaxel CARBOplatin
greater than or equal to and greater than or equal to 75 100% 100%
0.5
less than 0.5 and less than or equal to 75 80% 80%
less than 0.5 and greater than or equal to 75 80% 100%
greater than or equal to and less than or equal to 75 100% 80%
0.5
febrile neutropenia at any time 75% 80%
As noted above, if a delay due to hematologic recovery has occurred, extend all future cycles to 28 day
intervals.
2. Renal dysfunction: If significant increase (greater than 20%) in creatinine, repeat nuclear renogram
(if available) and recalculate CARBOplatin dose using new GFR.
3. Hepatic dysfunction:
Alkaline AST +/or ALT DOCEtaxel Dose
Phosphatase
less than 2.5 x ULN and less than or equal to 1.5 x ULN 100%
2.5 to 5 x ULN and 1.6 to 6 x ULN 60 mg/m2
greater than 5 x ULN or greater than 5 ULN discuss with contact physician
ULN= Upper limit of normal range
BC Cancer Protocol Summary GOCXCAD Page 3 of 4
Activated: 1 Aug 2003 Revised: 1 Jun 2022 (antiemetics revised)
Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to
apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at
your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/legal.htm
PRECAUTIONS:
1. Fluid Retention: dexamethasone premedication must be given to reduce incidence and severity of
fluid retention.
2. Hypersensitivity reactions to DOCEtaxel are common but it is not necessary to routinely initiate the
infusion slowly. If slow initiation of infusion is needed, start infusion at 30 mL/h x 5 minutes, then
60 mL/h x 5 minutes, then 120 mL/h x 5 minutes, then complete infusion at 250 mL/h (for 500 mL
bag, continue 250 mL/h for 5 minutes and then complete infusion at 500 mL/h). Refer to BC Cancer
Hypersensitivity Guidelines.
3. Extravasation: DOCEtaxel causes pain and may cause tissue necrosis if extravasated. Refer to BC
Cancer Extravasation Guidelines.
4. Neutropenia: Fever or other evidence of infection must be assessed promptly and treated
aggressively.
5. Hepatic Dysfunction: DOCEtaxel undergoes hepatic metabolism. Hepatic dysfunction (particularly
elevated AST) may lead to increased toxicity and usually requires a dose reduction. Baseline liver
enzymes are recommended before Cycle 1 and then if clinically indicated (e.g. – repeat lever
enzymes prior to each treatment if liver enzymes are elevated, liver metastases are present or there
is severe toxicity such as neutropenia). If liver enzymes are normal and there is no evidence of lever
metastases or severe toxicity, check liver enzymes after three cycles (i.e. – at Cycle 4). Note: this
information is intended to provide guidance, but physicians must use their clinical judgement when
making decisions regarding monitoring and dose adjustments.
Call Dr. Jenny Ko or tumour group delegate at (604) 851-4710 or 1-877-547-3777 with any problems
or questions regarding this treatment program.
References:
1. Vasey PA. Role of docetaxel in the treatment of newly diagnosed advanced ovarian cancer. J Clin
Oncol 2003;21(90100):136s-44s.
2. Benedetti Panici P, Bellati F, Plotti F, et al. Neoadjuvant chemotherapy followed by radical surgery in
patients affected by vaginal carcinoma. Gynecol Oncol. 2008;111(2):307-311.
3. Raspagliesi F, Zanaboni F, Martinelli F, Scasso S, Laufer J, Ditto A. Role of paclitaxel and cisplatin as
the neoadjuvant treatment for locally advanced squamous cell carcinoma of the vulva. J Gynecol
Oncol. 2014;25(1):22-29.
BC Cancer Protocol Summary GOCXCAD Page 4 of 4
Activated: 1 Aug 2003 Revised: 1 Jun 2022 (antiemetics revised)
Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to
apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at
your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/legal.htm
