BC Cancer Protocol Summary for Primary Treatment of Visible

Residual (Extreme Risk) Invasive Epithelial Ovarian, Fallopian Tube or

Peritoneal Cancer Using CARBOplatin and PACLitaxel

Protocol Code: GOOVCATX

Tumour Group: Gynecologic Oncology

Contact Physicians: Dr. Anna Tinker

ELIGIBILITY:
 visible residual, invasive epithelial ovarian, fallopian tube or peritoneal cancer, or borderline with
invasive implants

EXCLUSIONS:
 no visible residual disease (use protocol GOOVCATM or GOOVCADM)
 borderline (low malignant potential) tumours with non-invasive implant – contact BCCA
 prior chemotherapy or radiotherapy for this malignancy (use relapse protocols)
 uncontrolled brain metastases
 AST and/or ALT greater than 10 times the Upper Limit of Normal
 total bilirubin greater than 128 micromol/L

RELATIVE CONTRAINDICATIONS:
 pre-existing motor or sensory neuropathy greater than grade 2
 performance status greater than ECOG 3

INCOMPLETE PRIMARY SURGERY:

Responders with "incomplete" primary surgery i.e., debulking to less than 2 cm not carried out, should be
discussed for consideration of re-laparotomy after 3-4 cycles. Survival benefits may be realised with "interval
debulking" after several cycles of chemotherapy.

NO PRIMARY SURGERY:
If no primary surgery was carried out, these patients are candidates for interval debulking after three or four
cycles.

TESTS:
 Baseline: CBC & diff, platelets, creatinine, tumour marker (CA 125, CA 15-3, CA 19-9, CEA), LFT’s
(if abnormal liver function is a potential concern), camera nuclear renogram for GFR (optional)
 Day 14 (and Day 21 if using a 4 week cycle interval) of first cycle (and in subsequent cycle(s) if a
dose modification has been made): CBC & diff, platelets. No need for interim count check once safe
nadir pattern has been established.
 Before each treatment: CBC & diff, creatinine, any initially elevated tumour marker, LFT’s (if clinically
indicated).

PREMEDICATIONS:
 PACLitaxel must not be started unless the following drugs have been given:
45 minutes prior to PACLitaxel:
 dexamethasone 20 mg IV in 50 mL NS over 15 minutes
30 minutes prior to PACLitaxel:
 diphenhydrAMINE 50 mg IV and ranitidine 50 mg IV in 50 mL NS over 20 minutes
(compatible up to 3 hours when mixed in bag)
 ondansetron 8 mg po 30 minutes pre-CARBOplatin
BC Cancer Protocol Summary GOOVCATX Page 1 of 4
Activated: N/A Revised: 1 May 2019 (remove carboplatin escalation)
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
ANTIEMETIC THERAPY POST-CHEMOTHERAPY:
 Antiemetic protocol for moderate emetogenic chemotherapy protocols (see SCNAUSEA)
 dexamethasone 4 mg PO bid for 2 days and dimenhyDRINATE 50 to 100 mg PO prn after treatment
is usually adequate

TREATMENT (give PACLitaxel first):

Drug Starting Dose BCCA Administration Standard

2
PACLitaxel 175 mg/m * IV in 500 mL NS over 3 hours
(use non-DEHP bag and non-DEHP tubing
with 0.22 micron or smaller in-line filter)

CARBOplatin Dose = AUC** x (GFR +25) IV in 250 mL NS over 30 minutes

2 2
* Conservative dosing (i.e., 155 mg/m or 135 mg/m ) may be considered in the following
cases: ECOG greater than 2, existing or potential myelosuppression; existing or potential arthralgia
and myalgia; prior radiotherapy, particularly to the pelvic region; reduced bone marrow capacity. An
2
initial dose of 135 mg/m is recommended in patients greater than 75 years of age, with escalation to
2 2
155 mg/m and then 175 mg/m if tolerated.

** use AUC of 6; if extensive prior radiation therapy, use AUC of 5

Repeat every 21-28 days for 6 cycles. May extend to 9 cycles or until disease progression if the patient
has not achieved a complete response but is continuing to respond.

Measured GFR (e.g. nuclear renogram) is preferred in circumstances of co-morbidity that could affect
renal function (third-space fluid accumulations, hypoproteinemia, potentially inadequate fluid intake, age
greater than 70, 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

1.04 x (140 - age in years) x wt (kg)

GFR =
serum creatinine (micromol/L)

Recalculate GFR if, at a point of (optional) checking, creatinine increases by greater than 20% or rises
above the upper limit of normal.

If PACLitaxel toxicity is a concern or becomes problematic, consider use of single agent CARBOplatin
(GOOVCARB at AUC = 5) or protocols GOOVCAD or GOOVCAG.

BC Cancer Protocol Summary GOOVCATX Page 2 of 4

Activated: N/A Revised: 1 May 2019 (remove carboplatin escalation)
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
DOSE MODIFICATIONS:
1. Hematology:
a) on treatment day:
9 9
ANC (x 10 /L) Platelets (x 10 /L) Doses (both drugs)

greater than or equal to 1.0 and greater than or equal to 100 treat as per nadir (if applicable);
otherwise, proceed at same doses

less than 1.0* or less than 100 Delay until recovery. If using 21-day
interval, switch to 28-day interval. If
nd
2 delay, use filgrastim (G-CSF) or
dose reduction.
* If ANC greater than 0.8 and monocytes greater than or equal to 20%, neutrophil count recovery is likely
imminent. Continuation without delay may occur at physician’s discretion.

b) at nadir (until nadir pattern established):

9 9
ANC (x 10 /L) Platelets (x 10 /L) PACLitaxel CARBOplatin*

greater than or equal to 0.5 and greater than or equal to 75 100% 100%**

less than 0.5 and less than 75 80% 80%

less than 0.5 and greater than or equal to 75 80% 100%

greater than or equal to 0.5 and less than 75 100% 80%

febrile neutropenia at any time 80% 80%

* % of previous cycle’s dose, at physician’s discretion. If dose is changed, subsequent nadir counts must
be checked.
** If dose has been reduced, dose increase/re-escalation for good nadir counts is not recommended.

2. Arthralgia and/or myalgia: If arthralgia and/or myalgia of grade 2 (moderate) or higher was not
adequately relieved by NSAIDs or acetaminophen with codeine (e.g., TYLENOL#3®), a limited
number of studies report a possible therapeutic benefit using:
 predniSONE 10 mg PO bid x 5 days starting 24 hours post-PACLitaxel
 gabapentin 300 mg PO on day before chemotherapy, 300 mg bid on treatment day, then 300 mg
tid x 5 to 15 days (based on duration of arthromyalgia)
2
If arthralgia and/or myalgia persists, reduce subsequent PACLitaxel doses to 135 mg/m or switch
taxane to DOCEtaxel (GOOVCADX)

3. Neuropathy: Dose modification or discontinuation may be required (see BCCA Cancer Drug
Manual).

4. Renal dysfunction: If significant increase (greater than 20% or rises above the upper limit of normal)
in creatinine, recheck/recalculate GFR and recalculate CARBOplatin dose using new GFR.

BC Cancer Protocol Summary GOOVCATX Page 3 of 4

Activated: N/A Revised: 1 May 2019 (remove carboplatin escalation)
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
5. Hepatic dysfunction: Dose reduction may be required for PACLitaxel
ALT Bilirubin Dose
2
less than 10 x ULN and less than or equal to 1.25 x ULN 175 mg/m
2
less than 10 x ULN and 1.26 to 2 x ULN 135 mg/m
2
less than 10 x ULN and 2.01 to 5 x ULN 90 mg/m

greater than or equal to 10 x and/or greater than 5 x ULN not recommended

ULN

PRECAUTIONS:
1. Hypersensitivity: Reactions are common. See BCCA Hypersensitivity Guidelines
Mild symptoms (e.g., mild flushing, rash,  complete PACLitaxel infusion. Supervise at bedside
pruritus)
 no treatment required

Moderate symptoms (e.g. moderate rash,  stop PACLitaxel infusion

flushing, mild dyspnea, chest discomfort,
 give IV diphenhydrAMINE 25 to 50 mg and
mild hypotension
hydrocortisone IV 100 mg
 after recovery of symptoms resume PACLitaxel
infusion at 20 mL/h for 5 minutes, 30 mL/h for
5 minutes, 40 mL/h for 5 minutes, then 60 mL/h for
5 minutes. If no reaction, increase to full rate.
 if reaction recurs, discontinue PACLitaxel therapy

Severe symptoms (i.e. one or more of  stop PACLitaxel infusion

respiratory distress requiring treatment,
 give IV antihistamine and steroid as above. Add
generalised urticaria, angioedema,
epinephrine or bronchodilators if indicated
hypotension requiring therapy)
 discontinue PACLitaxel therapy

2. Extravasation: PACLitaxel causes pain and may, rarely, cause tissue necrosis if extravasated. Refer
to BCCA Extravasation Guidelines.
3. Neutropenia: Fever or other evidence of infection must be assessed promptly and treated
aggressively.
4. Drug Interactions: PACLitaxel is a CYP 2C8/9 and CYP 3A4 substrate. Drug levels may be
increased by inhibitors of these enzymes and decreased by inducers of these enzymes.

Call Dr. Anna Tinker or tumour group delegate at (604) 877-6000 or 1-800-663-3333 with any
problems or questions regarding this treatment program.

BC Cancer Protocol Summary GOOVCATX Page 4 of 4

Activated: N/A Revised: 1 May 2019 (remove carboplatin escalation)
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