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Lenalidomide and Doxorubicin Hydrochloride Liposome in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2009
First Received: May 15, 2009   Last Updated: August 26, 2009   History of Changes
Sponsors and Collaborators: Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00903630
  Purpose

RATIONALE: Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with doxorubicin hydrochloride liposome may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with doxorubicin hydrochloride liposome in treating patients with recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: lenalidomide
Drug: pegylated liposomal doxorubicin hydrochloride
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: WCC #50 - Phase I Trial of Lenalidomide in Combination With Liposomal Doxorubicin for the Treatment of Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose of lenalidomide [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity according to NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Disease response according to RECIST criteria [ Designated as safety issue: No ]
  • Time to progression (duration of response) [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2009
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of lenalidomide when combined with fixed dose pegylated liposomal doxorubicin hydrochloride in women with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Secondary

  • To obtain preliminary information on toxicity, response, and time to progression (duration of response) of these patients.

OUTLINE: This is a dose-escalation study of lenalidomide.

Patients receive oral lenalidomide once daily on days 1-28 and pegylated liposomal doxorubicin hydrochloride IV on day 1. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 12 weeks for 3 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer

    • Disease has recurred or is resistant to prior treatment with at least 1 platinum-based regimen and meets ≥ 1 of the following criteria:

      • Platinum-refractory disease, defined as progression during the first 6 courses of first-line therapy with a platinum-based regimen
      • Platinum-resistant disease, defined as progression within 6 months after completing first-line platinum-based chemotherapy
      • Platinum-sensitive disease, defined as progression > 6 months after completing first-line platinum-based chemotherapy
      • Disease that has progressed while receiving or recurred within 6 months after completing platinum-based second-line therapy
    • Patients who have experienced failure of a second line therapy > 6 months after completing treatment or who have received more than 2 prior chemotherapy regimens are not eligible
  • No diagnosis of borderline or low malignant potential epithelial carcinoma
  • Measurable disease per RECIST criteria, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

    • Patients without measurable disease may enter with elevated CA 125 levels if previously normal or stable CA 125 levels are documented after the completion of the prior chemotherapy regimen

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Serum creatinine ≤ 1.5 mg/dL
  • Total bilirubin < 1.2 mg/dL
  • AST and ALT ≤ 2 times upper limit of normal (ULN) (≤ 5 times ULN if hepatic metastases are present)
  • LVEF normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception beginning at least 28 days before study treatment
  • Peripheral neuropathy ≤ grade 2 (CTCAE v 3.0)
  • No HIV positivity
  • No infectious hepatitis A, B, or C positivity
  • Progression-free of prior malignancies for at least 5 years, except currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin)
  • No serious medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, would prevent the patient from signing the consent form
  • No history of myocardial infarction, congestive heart failure, or arrhythmia requiring medication
  • No history of uncontrolled hypertension
  • No history of systolic or diastolic dysfunction
  • No EKG evidence of ventricular hypertrophy, conduction abnormality, or serious arrhythmia
  • No deep vein thromboembolism within the past 6 months
  • No history of thrombocytopenia or bleeding disorders
  • No condition, including the presence of laboratory abnormalities, that places the patient at unacceptable risk if she were to participate in the study or confounds the ability to interpret data from the study
  • No known hypersensitivity reaction > grade 2 to thalidomide or structurally related compounds
  • No development of erythema nodosum, if characterized by a desquamating rash while taking thalidomide or similar drugs
  • No uncontrolled hyper- or hypocalcemia, hyper- or hypoglycosemia, or hyper- or hypothyroidism

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Patients who are taking a stable or decreasing dose of concurrent systemic steroids during the study must agree to also take low-dose acetylsalicylic acid (aspirin) and/or other platelet-active, antithrombotic medication during and for 30 days after study treatment
  • At least 28 days since prior cancer therapy, including chemotherapy, hormonal therapy, and surgery
  • At least 2 weeks since prior thalidomide or structurally related compounds, radiotherapy, or biologic response modifiers
  • More than 28 days since prior experimental drug or therapy
  • No prior lenalidomide or pegylated liposomal doxorubicin hydrochloride
  • No other concurrent anticancer agents or treatments
  • No other concurrent chemotherapies, immunotherapies, or investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903630

Locations
United States, Minnesota
University of Minnesota Medical Center - Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Levi S Downs Jr     612-626-6628        
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Levi S. Downs, MD Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided

Responsible Party: Masonic Cancer Center at University of Minnesota ( Levi S. Downs, Jr )
Study ID Numbers: CDR0000642014, UMN-2008LS047
Study First Received: May 15, 2009
Last Updated: August 26, 2009
ClinicalTrials.gov Identifier: NCT00903630     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Lenalidomide
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian Epithelial Cancer
Abdominal Neoplasms
Doxorubicin
Fallopian Tube Neoplasms
Recurrence
Genital Diseases, Female
Anti-Bacterial Agents
Digestive System Diseases
Peritoneal Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Digestive System Neoplasms
Ovarian Neoplasms
Antineoplastic Agents
Gonadal Disorders
Lenalidomide
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Antibiotics, Antineoplastic
Abdominal Neoplasms
Pharmacologic Actions
Doxorubicin
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Digestive System Diseases
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Peritoneal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009