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Open Trial of Bendamustine HCL in Women With Advanced Ovarian Cancer
This study is ongoing, but not recruiting participants.

First Received on March 20, 2009.   Last Updated on March 10, 2011   History of Changes
Sponsor: University of Arizona
Collaborator: Cephalon
Information provided by: University of Arizona
ClinicalTrials.gov Identifier: NCT00867503
  Purpose

The study design is a non-randomized, open label, single center Phase II trial. Eligible patients are women who have a confirmed diagnosis of ovary, fallopian tube cancer or primary peritoneal serous papillary carcinoma who have relapsed or are refractory to therapy after primary treatment of their disease.

Patients will be treated with bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2. 20 patients will be enrolled in the study.

OBJECTIVES Hypothesis/Rationale: To determine the efficacy and safety of bendamustine hydrochloride, in women with platinum and taxane refractory ovarian cancer.


Condition Intervention Phase
Ovarian Cancer
Drug: Bendamustine HCL
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Phase II Trial of Bendamustine HCL in Women With Advanced Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • To evaluate the response rates (confirmed, complete and partial), and response durations to bendamustine in patients with platinum and taxane refractory ovarian cancer, fallopian tube cancer and primary peritoneal cancer. [ Time Frame: life of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the toxicities of patients treated with bendamustine. [ Time Frame: Life of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: April 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bendamustine
bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
Drug: Bendamustine HCL
bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.

Detailed Description:

Bendamustine, a non-cross resistant cytotoxic, has potential to offer a new regimen for the treatment of ovarian cancer in women who are refractory to standard drug regimens. Non-cross resistance to platinum is critical for the development of effective salvage regimens in this platinum resistant population. In addition bendamustine's cytotoxic effects are thought to occur via several mechanistic pathways, apoptosis, DNA repair, DNA replication, DNA transcription. The study seeks to determine the efficacy and safety of bendamustine in women with advanced ovarian cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Patients must have histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary, fallopian tube cancer or primary peritoneal serous papillary carcinoma. Borderline ovarian tumors are not allowed.

2 Patients must have relapsed within 6 months of completing, or had a best response of increasing disease during any number of prior chemotherapy regimens with a platinum (either cisplatin or carboplatin) and a taxane (paclitaxel or docetaxel). These agents may have been administered concurrently or sequentially. Any number of additional regimens for recurrent disease will be allowed, as long as the patient performance status is 0-2 GOG.

3 Patients must have measurable or evaluable (i.e. positive serum CA-125 marker) disease. Scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration. Scans or ultrasounds for non -measurable disease must have been performed within 28 days prior to registration.

4 Prior radiation is allowed as long as it encompassed no more than 25% of the bone marrow. Debulking surgery for relapsed disease is allowed as long as the patient has measurable or evaluable disease remaining after the surgery. Patient must have recovered from all side effects of surgery.

5 Patients must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to registration. Patients must not have had a major surgery within 14 days prior to registration.

6 Patients must have a GOG performance status of 0-2.

7 Patients must have adequate liver function as defined by a serum bilirubin ≤2.0 x the institutional upper limit of normal (IULN), SGOT or SGPT ≤2.5 x the institutional upper limit of normal obtained within 14 days prior to registration.

8 Patients must have an adequate renal function as defined by a serum creatinine ≤1.5x the institutional upper limit of normal obtained within 14 days prior to registration

9 Patients must not have Class 3 /4 cardiac problems as defined by the New York Heart Association Criteria (e.g., congestive heart failure, myocardial infarction within 2 months of study)

10 Patients must not be pregnant or nursing as bendamustine maybe harmful to the developing fetus and newborn. Women of reproductive potential must have a negative serum pregnancy test within 7 days prior to registration. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.

11 No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

12 Patients must have the following hematological criteria: Hemoglobin of ≥9gm/dL White blood cell count ≥ 2500 Platelets ≥ 100,000

13 Patients must be ≥ 18 years of age.

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Exclusion Criteria:

  1. No borderline ovarian tumors and mixed mesodermal soft tissue sarcomas
  2. No psychological, familial, sociological, or geographical conditions that do not permit medical follow-up or compliance with the study protocol
  3. Except for cancer-related abnormalities, patients should not have unstable or preexisting major medical conditions
  4. No medical life-threatening complications of their malignancies
  5. No known severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, active uncontrolled infection, or HIV)
  6. Inadequately controlled hypertension (defined as systolic blood pressure ≥ 150 and/or diastolic blood pressure ≥100 mmHg on antihypertensive medications)
  7. New York Heart Association (NYHA) Grade III or greater congestive heart failure
  8. Evidence of 5 to ≤10% loss of weight from baseline (baseline defined as the screening weight taken approximately 14 days of Day 0) that is not related to ascites or paracentesis.
  9. Evidence of uncontrollable nausea
  10. Presence of central nervous system or brain metastases
  11. Known hypersensitivity to any component of bendamustine HCL

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867503

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Cephalon
Investigators
Principal Investigator: Setsuko K Chambers, MD University of Arizona
  More Information

No publications provided

Responsible Party: Setsuko K. Chambers, M.D., Arizona Cancer Center, University of Arizona
ClinicalTrials.gov Identifier: NCT00867503     History of Changes
Other Study ID Numbers: 08-1137-04
Study First Received: March 20, 2009
Last Updated: March 10, 2011
Health Authority: United States: University of Arizona Human Subjects Protection Program

Keywords provided by University of Arizona:
ovarian cancer
bendamustine

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Bendamustine
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012