Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer.
N/A
75 Years
Female
Ovarian Cancer
Trial Information
Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer.
Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer.
Standard combination chemotherapy with a platinum derivative (cisplatin or carboplatin) and
a taxane are effective in causing remission in 60 - 80 % of cases, yet recurrences are
frequent and 5-year survival is only 20%. Current therapies for second line treatment of
recurrence in patients who have platinum refractory (who experienced progression of the
disease during first line platinum based therapy) or platinum resistant (who experienced a
recurrence of the disease within 6 months of completing platinum based therapy)ovarian
cancer are limited. Capecitabine, an oral chemotherapy already used in colon and breast
cancers, has shown some promise in early clinical trials for treating recurrent ovarian
cancer.
Patients entered into this trial will receive oral capecitabine 1250 mg/m2 on days 1-14
every 21 days for up to 6 cycles, depending on response.
Inclusion Criteria:
- Cytologic or histologic diagnosis of relapsed ovarian cancer
- Refractory or resistant to platinum salts disease
- Age < 75 years
- At least one measurable lesion (³ 20 mm with conventional techniques or ³ 10 mm with
spiral CT scan)
- Life expectancy of at least 3 months
- Written informed consent
Exclusion Criteria:
- Previous or concomitant malignant neoplasia within 5 years prior to basal evaluation
(excluding adequately treated basocellular or spinocellular skin carcinoma or in situ
carcinoma of the uterine cervix).
- Performance Status (ECOG) ³ 3
- Previous chemotherapy treatment with capecitabine
- More than 3 lines of chemotherapy
- Heart disease (heart failure, heart attack during the 6 months prior to the trial,
atrioventricular block of any degree, serious arrhythmia)
- Leukocytes < 4000/mm3, platelets < 100000/mm3
- Modifications of renal function (Creatinine ³ 1.25 times the upper normal limit) or
liver function (SGOT or SGPT ³ 1.25 times the upper normal limit)
- Present or suspected haemorrhagic syndromes
- Uncooperative and/or unreliable patients
- Patients' inability to access the centre
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
objective response rate
Principal Investigator
Sandro Pignata, M.D., Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute, Naples
Authority:
Italy: Ethics Committee
Study ID:
MITO-6
NCT ID:
NCT00403429
Start Date:
March 2006
Completion Date:
July 2008
Related Keywords:
- Ovarian Cancer
- oral chemotherapy
- platinum resistant
- platinum refractory
- second line
- Ovarian Neoplasms
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