ANNEX 3
LONDON GYNAECOLOGICAL ONCOLOGY GROUP
MINUTES OF
THE MEETING
HELD ON
10 JANUARY 1995 GUY'S
HOSPITAL, LONDON
Present:
1. APOLOGIES
Apologies were received from John Shepherd and
Robin Crawford.
2.2 MINUTES OF
THE LAST
MEETING
The minutes of the previous meeting were deemed
to be correct.
3. MATTERS ARISING
None not covered by agenda items.
4. BB94 STUDY
(BATIMASTAT)—RICHARD
OSBORNE
The medical representatives from the manufacturers
of Batimastat attended at Richard Osborne's request to discuss
the toxicity of the current study on intraperitoneal Batimastat.
It was commented that the particular symptoms of abdominal pain
and of ileus, nausea and vomiting were being seen more frequently
in this Phase 3 study than in John Smyth's Phase 1/2 study. Notably
5/9 patients in this study had had severe nausea and vomiting
(0/5 in the control arm) in comparison with only 5/23 in John
Smyth's study.
Differences in Batimastat administration that
could be identified were:
1. In the original study Batimastat was warmed
to 37 whereas in the present study it is delivered at room
temperature.
2. In the present study patients are on Spironclactone
which was not a regular medication in John Smyth's study.
The suggestion is that in the first instance
Batimastat is delivered at 37 but that the Spironclactone
regimen continues for the present time. A standard anti-emetic
policy should be used and this will be Cyclizine50 mg tds.
The incidence of nausea and vomiting will be
monitored and if a further three patients have severe nausea and
vomiting Spironclactone will be started on day three instead of
day one. The whole study will be reviewed in the LGOG meeting
in three months.
5. HIGH DOSE
CHEMOTHERAPY WITH
GROWTH FACTOR
AND PERIPHERAL
BLOOD STREAM
CELL SUPPORT
FOR ADVANCED
CARCINOMA OF
THE OVARY—JONATHAN
LEDERMANN
This proposed Phase II protocol is appended
and would be for the treatment of patients with histologically
proven Stage IIb, III and IV carcinoma of the ovary who have undergone
four courses of Platinum-based chemotherapy and who appear to
be in complete remission on CA125 estimation and CT scanning.
The chemotherapy regimen was discussed at length
and the combination of high dose Carboplatin, Cyclophosphamide
and Etoposide was thought to be as suitable as any. However, concern
was expressed that high dose Cazboplatin could produce unacceptable
neuropathy if Cisplatin were contained in the four induction courses.
Therefore, it was felt that either Cisplatin should not be included
or alternatively Cisplatin should be a requirement of the induction
chemotherapy within this pilot study and the true incidence of
neuropathy documented. It would be unacceptable for there to be
only a few patients with Cisplatin as part of the induction regimen
who were not the object of specific study regarding neuropathy.
It was agreed that Jonathan Ledermann would circulate the protocol
with these minutes and that he would report back to the LGOG when
10 patients had been treated. So far three patients have been
treated with various toxicities, including prolonged thrombocytopenia
resulting in GI haemorrhage and also severe mucositis.
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