Status:
WITHDRAWN
Phase 2 Study of Twice Weekly VELCADE and CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This a Phase 2, multicenter open label, uncontrolled 2-step design. Patients will be arranged in two groups based upon the response to their last platinum containing therapy. The two groups are, 1) Pl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00610792
Start Date
July 1 2006
Last Update
July 14 2009
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Division of Gynecologic Oncology, Università Catholica Sacre Cuore
Campbasso, Italy
2
Istituto Europeo di Oncologia (IEO)
Milan, Italy
3
Istituto Nazionale dei Tumori
Milan, Italy
4
Dept. Procreational Medicine, Università di Pisa
Pisa, Italy