Lenalidomide and Doxorubicin Hydrochloride Liposome in Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

NCT00903630 | Terminated Phase 1 Results DMC

• 4 other identifiers: 2008LS0470805M32463WCC #50RV-OVAR-PI-0447
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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/II 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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; fallopian tube cancer; peritoneal cavity cancer

Outcome Measures

Primary Outcomes (3)

• Phase 1 - Maximum Tolerated Dose (MTD) of Lenalidomide When Combined With Fixed Dose Liposomal Doxorubicin in Women With Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

  The maximum tolerated dose (MTD) reflects the highest dose of Lenalidomide when combined with fixed dose Liposomal Doxorubicin at which no more than one out of 6 participants experiences a dose limiting toxicity (DLT).

  1 cycle (28 days)

• Phase 1 - Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

  DLT is defined as the inability to complete cycle 1 and/or begin cycle 2 within 7 days of the planned start due to a grade 4 or greater hemtologic toxicity or a grade 3 or greater non-hematologic toxicity. Grading was based on Common Toxicity Criteria (CTC) Version 4.

  within 5 weeks of starting treatment

• Phase 2 - Number of Subjects Achieving a Partial or Complete Response

  Partial response is defined as: At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met. Complete response is defined as: The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.

  3 months after starting treatment

Secondary Outcomes (2)

• Phase 2 - Number of Subjects Who Are Progression-Free and Alive

  3 months after starting treatment

• Phase 2 - Number of Subjects Who Are Progression-Free and Alive

  6 months after starting treatment

Study Arms (3)

Phase 1 - Dose Level 1

EXPERIMENTAL

liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days

Drug: Lenalidomide; Drug: liposomal doxorubicin

Phase I - Dose Level 2

EXPERIMENTAL

liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days

Drug: Lenalidomide; Drug: liposomal doxorubicin

Phase 2

EXPERIMENTAL

liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days

Drug: Lenalidomide; Drug: liposomal doxorubicin

Interventions

Lenalidomide DRUG

administered by mouth at the assigned dose daily for each 28 day cycle

Also known as: Revlimid

Phase 1 - Dose Level 1; Phase 2; Phase I - Dose Level 2

liposomal doxorubicin DRUG

administered at a fixed dose of 40 mg/m\^2 intravenously (IV) on day 1 of each 28 day cycle

Also known as: Caelyx®

Phase 1 - Dose Level 1; Phase 2; Phase I - Dose Level 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer which has recurred or is resistant to prior treatment with at least one platinum based regimen and meeting at least one of the following criteria:
• Platinum refractory - progression during the first six cycles of first line therapy with a platinum based regimen
• Platinum resistant - progression within 6 months of completing first line platinum based chemotherapy
• Platinum sensitive - progression more than 6 months of completing first line platinum based chemotherapy
• Disease that has progressed while receiving or recurred within 6 months of completing platinum based second-line therapy Patients who have failed a second line therapy more than 6 months after completing treatment or have had more than 2 prior chemotherapy regimens will not be eligible for this study.
• Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria defined as one or more lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> or = 20 mm with conventional techniques (CT, PET/CT, MRI, X-ray) or as \> or = 10 mm with spiral CT scan.
• Patients entering the study during the dose escalation component who do not meet the measurable disease requirement may enter with elevated CA 125 levels only if previously normal or stable CA 125 levels are documented after the completion of the prior chemotherapy regimen.
• Age \> or = 18 years at the time of signing of consent form
• Gynecologic Oncology Group (GOG) performance status of \< or = 2
• Laboratory test results within these ranges within 14 days prior to study registration:
• Absolute neutrophil count \> or = 1.5 x 10\^9/L
• Platelet count \> or = 100 x 10\^9/L
• Serum creatinine \< or = 1.5 mg/dL
• Total bilirubin \< 1.2 mg/dL
• AST (SGOT) and ALT (SGPT) \< or = 2 x upper limit of institutional normal (ULN) or \< or = 5 x ULN if hepatic metastases are present.

You may not qualify if:

• Histologic diagnosis of borderline or low malignant potential epithelial carcinoma.
• Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, would prevent the patient from signing the consent form.
• Prior history of myocardial infarction, congestive heart failure, or arrhythmia requiring medication. History of uncontrolled hypertension. History of systolic or diastolic dysfunction. EKG evidence of ventricular hypertrophy, conduction abnormality, or serious arrhythmia.
• History of deep vein thromboembolism (DVT) within the previous 6 months, history of thrombocytopenia or bleeding disorders.
• Pregnant or breast feeding females. Lenalidomide is pregnancy category X.
• Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or therapy within 28 days of study registration.
• Known hypersensitivity reaction \> grade 2 to thalidomide or structurally related compounds
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
• Any prior use of lenalidomide or liposomal doxorubicin
• Concurrent use of other anti-cancer agents or treatments
• Known positive for HIV or infectious hepatitis, type A, B or C
• Uncontrolled hyper- or hypo- calcemia, glycosemia or thyroidism

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Minnesota Medical Center - Fairview

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Lenalidomide; liposomal doxorubicin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Levi Downs, Jr
• Organization: University of Minnesota, Dept. of OBGYN

downs008@umn.edu

612-626-3111

Study Officials

• Levi S. Downs, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 18, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 28, 2017
• Results First Posted: January 18, 2017

Record last verified: 2017-12

Locations

US (1)