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An Open Label, Phase 2 Study of Biweekly VELCADE and Intermittent CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens


Phase 2
18 Years
75 Years
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

An Open Label, Phase 2 Study of Biweekly VELCADE and Intermittent CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens


Inclusion Criteria:



- Histologically/cytologically confirmed diagnosis of ovarian carcinoma of epithelial
origin, primary tubal or peritoneal carcinoma;

- Progressive or recurrent disease

- The following patient types based upon the disease measurability may enroll in this
study and will be considered for efficacy evaluation.

Patients may have measurable disease strictly following the RECIST guidelines. CA125
levels must be obtained according to the Rustin guidelines to enable a complete evaluation
of response/progressive disease according to the GCIG guidelines. Patients may enter with
a solitary measurable lesion which has not been confirmed by histology/cytology. These
patients will be considered evaluable for response according to a modified RECIST which
will not require the histological/cytological confirmation of the lesion. CA125 levels
must be obtained according to the Rustin guidelines to enable a complete evaluation of
progressive disease according to the GCIG guidelines. Patients with non-measurable disease
will be considered evaluable for response provided CA125 data has been collected according
to the Rustin guidelines and a complete evaluation of response/progressive disease
according to the GCIG guidelines maybe conducted.

- Numbers of prior chemotherapy(s): maximum 2 prior chemotherapies. Reintroduction of a
platinum at relapse, after an initial response lasting > 6 months is considered 1
chemotherapy regimen only.

- ECOG performance status grade 0 or 1

- Age ≥ 18 and ≤ 75 yrs

- Adequate hematological, liver and renal function (hemoglobin ≥ 9 g/dL, absolute
neutrophil count (ANC) ≥ 1.50 x 109/L; platelets ≥ 100 x 109/L, bilirubin within UNL;
alkaline phosphatase ≤ 1.5 x UNL; ALT, AST ≤ UNL or ≤ 2.5 x UNL in case of liver
metastases; albumin ≥ 2.5 g/dL; creatinine ≤ UNL

- Life expectancy of at least 3 months

- Prior anthracycline limited to doxorubicin equivalent of 280mg/m2 with progression
free interval of at least 12 months for patients who have been pre-treated with
CAELYX

- LVEF must be within normal limits

- Signed and dated informed consent

Exclusion Criteria:

- Chemotherapy, hormonal, radiation or immunotherapy or participation in any
investigational drug study within 4 weeks of study entry

- Pre-existing peripheral neuropathy > Grade 1

- Presence of cirrhosis or active or chronic hepatitis

- Presence of serious cardiac (congestive heart failure, angina pectoris, myocardial
infarction within one year prior to study entry, uncontrolled hypertension or
arrhythmia), neurological or psychiatric disorder

- Presence of uncontrolled intercurrent illness or any condition which in the judgment
of the Investigator would place the subject at undue risk or interfere with the
results of the study

- Symptomatic brain metastases or leptomeningeal disease

- Pregnancy or lactation or unwillingness to use adequate method of birth control

- Active infection

- Known history of allergy to mannitol, boron or liposomally formulated drugs.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

tumor response, as measured using the Gynecologic Cancer Intergroup (GCIG) recommendations (modified RECIST); duration of response and progression free interval

Outcome Time Frame:

baseline scans performed up to 4 weeks prior to start of treatment; further assessments at end of cycle 2; confirmation is required

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

Italy: The Italian Medicines Agency

Study ID:

26866138-OVC-2001

NCT ID:

NCT00610792

Start Date:

July 2006

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms

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