Phase 2 Study of Twice Weekly VELCADE and CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00610792
Recruitment Status : Withdrawn (Study never submitted to IND. Study is being sponsored by Johnson and Johnson in the EU only.)
First Posted : February 8, 2008
Last Update Posted : July 14, 2009
Information provided by:
Millennium Pharmaceuticals, Inc.

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) Platinum Resistant Patients: patients with progressive disease while on platinum containing therapy or stable disease after at least 4 cycles; patients relapsing following an objective response while still receiving treatment; patients relapsing after an objective response within 6 months from the discontinuation of the last chemotherapy and 2) Platinum-Sensitive Patients: patients who relapsed following an objective response after 6 months from the discontinuation of platinum containing chemotherapy. All patients will receive pyridoxine at least 200mg by mouth daily beginning approximately one week prior to the initiation of the combination chemotherapy and it will continue up to the end of the last treatment cycle.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: bortezomib Drug: pegylated liposomal doxorubicin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 91 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase 2 Study of Biweekly VELCADE and Intermittent CAELYX in Patients With Ovarian Cancer Failing Platinum Containing Regimens
Study Start Date : July 2006
Estimated Primary Completion Date : September 2009

Arm Intervention/treatment
Experimental: 1 Drug: bortezomib
1.3 mg/m2 on Days 1, 4, 8 & 11 every 3 weeks (1 cycle = 21 days) for up to six cycles
Other Name: VELCADE
Drug: pegylated liposomal doxorubicin
30 mg/m2 on Day 1 every 3 weeks (1 cycle = 21 days) for up to six cycles
Other Name: CAELYX

Primary Outcome Measures :
  1. tumor response, as measured using the Gynecologic Cancer Intergroup (GCIG) recommendations (modified RECIST); duration of response and progression free interval [ Time Frame: baseline scans performed up to 4 weeks prior to start of treatment; further assessments at end of cycle 2; confirmation is required ]

Secondary Outcome Measures :
  1. Overall safety profile of the combination characterized by type, frequency, severity, timing and relationship to study therapy of adverse events and laboratory abnormalities (NCI-CTCAE V3.0) [ Time Frame: Patients followed for adverse events for 30 days after the last drug administration, or until all drug related toxicities and ongoing SAEs havebeen resolved ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00610792

Division of Gynecologic Oncology, Università Catholica Sacre Cuore
Campbasso, Italy
Istituto Europeo di Oncologia (IEO)
Milan, Italy
Istituto Nazionale dei Tumori
Milan, Italy
Dept. Procreational Medicine, Università di Pisa
Pisa, Italy
Kantonsspital St. Gallen
St. Gallen, CH, Switzerland
Gynecologic Oncology Unit
Ospedale Sant' Anna, Turin, Switzerland
Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.

Responsible Party: Clinical Study Medical Monitor, Millennium Pharmaceuticals, Inc. Identifier: NCT00610792     History of Changes
Other Study ID Numbers: 26866138-OVC-2001
First Posted: February 8, 2008    Key Record Dates
Last Update Posted: July 14, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action