Paclitaxel With or Without Viral Therapy in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

NCT01199263 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI-2011-02654CDR0000684693GOG-0186HU10CA180868U10CA027469
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 36

Brief Summary

This randomized phase II trial studies the side effects and how well giving paclitaxel with or without viral therapy works in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them spreading. Viral therapy may be able to kill tumor cells without damaging normal cells. Giving paclitaxel together with viral therapy may kill more tumor cells.

Conditions

Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival (PFS)

  Time from patient entry until progression, death, or date last seen. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  Approximately 4.5 years.

• Number of Participants With Adverse Events Grade 3 or Greater as Assessed by CTCAE Version 4.0

  The frequency and severity of Grade 3 and above toxicities are tabulated.

  approximately 4.5 years

Secondary Outcomes (3)

• Percentage of Participants withTumor Response by RECIST

  approximately 4.5 years

• Median Overall Survival (OS) by Treatment Group

  After patient stops protocol therapy, she is followed quarterly for 2 years, semi-annually for 3 more years, approximately 4.5 years.

• Tumor Response by CA125

  Before every cycle, approximately 4.5 years.

Study Arms (2)

Arm I (paclitaxel)

EXPERIMENTAL

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.

Other: Laboratory Biomarker Analysis; Drug: Paclitaxel

Arm II (paclitaxel and wild-type reovirus)

EXPERIMENTAL

Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.

Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: Pelareorep

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (paclitaxel); Arm II (paclitaxel and wild-type reovirus)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm I (paclitaxel); Arm II (paclitaxel and wild-type reovirus)

Pelareorep BIOLOGICAL

Given IV

Also known as: PO BB0209, PO-BB0209, Reolysin, Reovirus Serotype 3, Wild-type Reovirus

Arm II (paclitaxel and wild-type reovirus)

Eligibility Criteria

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

You may qualify if:

• Patients must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
• Patients must have measurable disease or detectable (non-measurable) disease:
• Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by computed tomography \[CT\], magnetic resonance imaging \[MRI\] or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \> 15 mm in short axis when measured by CT or MRI
• Detectable (non-measurable) disease is defined as not having measurable disease but has at least one of the following conditions:
• Baseline values of CA-125 at least 2 x upper limit of normal (ULN);
• Ascites and/or pleural effusion attributed to tumor;
• Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
• Patient with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
• Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III protocol or rare tumor protocol for the same patient population
• Patients who have received one prior regimen must have a GOG performance status of 0, 1, or 2
• Patients who have received two or three prior regimens must have a GOG performance status of 0 or 1
• Recovery from effects of recent surgery, radiotherapy, or chemotherapy:
• Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \[UTI\])
• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
• Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted and immunologic agents, must be discontinued at least three weeks prior to registration

You may not qualify if:

• Patient who have had previous treatment with Reolysin or other oncolytic virus; patients who have had previous treatment with weekly paclitaxel for recurrent or persistent disease
• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
• Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
• Patients with a past history of primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serious, clear cell or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
• Patients with known human immunodeficiency virus (HIV) or hepatitis B or C are excluded due to risk of viral infectivity of Reolysin therefore patients with a pre-existent infection are not eligible
• Patients who are receiving immunosuppressive therapy including chronic oral steroids (at an equivalent dose of greater than prednisone 5 mg daily)
• Women who are pregnant or nursing; pregnant women are excluded from this study; breastfeeding should be discontinued while the mother is being treated with the agents in this clinical trial
• Myocardial infarction or unstable angina within 6 months of the first date of study therapy
• History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication)
• Troponin \> ULN
• Baseline ejection fraction \< 50% as assessed by echocardiogram or multi gated acquisition scan (MUGA)
• New York Heart Association (NYHA) class II or greater congestive heart failure
• History of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of study therapy

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• NRG Oncology: collaborator

Study Sites (36)

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States

Location

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View, California, 94040, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

Northeast Georgia Medical Center-Gainesville

Gainesville, Georgia, 30501, United States

Location

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States

Location

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, 48106, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Beaumont Hospital - Dearborn

Dearborn, Michigan, 48124, United States

Location

Ascension Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Allegiance Health

Jackson, Michigan, 49201, United States

Location

Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Saint Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Saint Joseph Mercy Oakland

Pontiac, Michigan, 48341, United States

Location

Lake Huron Medical Center

Port Huron, Michigan, 48060, United States

Location

Ascension Saint Mary's Hospital

Saginaw, Michigan, 48601, United States

Location

Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89169, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

Atrium Health Cabarrus/LCI-Concord

Concord, North Carolina, 28025, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States

Location

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

Location

Carilion Clinic Gynecological Oncology

Roanoke, Virginia, 24016, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Paclitaxel; Taxes; reolysin

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Results Point of Contact

• Title: Linda Gedeon for Michael Sill, PhD
• Organization: NRG Oncology

linda.gedeon@roswellpark.org

716-845-1169

Study Officials

• David E Cohn

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: December 6, 2010
• Primary Completion: June 1, 2015
• Study Completion: July 17, 2020
• Last Updated: September 16, 2020
• Results First Posted: October 30, 2019

Record last verified: 2020-08

Locations

US (36)