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

This study is currently recruiting participants.
Verified January 2014 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01199263
First received: September 9, 2010
Last updated: April 21, 2014
Last verified: January 2014
  Purpose

This randomized phase II trial is studying 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. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Viral therapy may be able to kill tumor cells without damaging normal cells. Giving chemotherapy together with viral therapy may kill more tumor cells.


Condition Intervention Phase
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Biological: wild-type reovirus
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A RANDOMIZED PHASE II EVALUATION OF WEEKLY PACLITAXEL (NSC# 673089) VERSUS WEEKLY PACLITAXEL WITH ONCOLYTIC REOVIRUS (REOLYSIN NSC # 729968, BB-IND #13370) IN THE TREATMENT OF RECURRENT OR PERSISTENT OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Median PFS by treatment group [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The Cox proportional hazards ratio for patients with measurable disease to non-measurable disease, the Kaplan-Meier estimates of each population.

  • Median overall survival (OS) by treatment group [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The Cox proportional hazards ratio for patients with measurable disease to non-measurable disease, the Kaplan-Meier estimates of each population.

  • Tumor response by RECIST and CA-125 criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: December 2010
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (paclitaxel)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Experimental: Arm II (paclitaxel and wild-type reovirus)
Patients receive paclitaxel as in arm I and wild-type reovirus IV over 1 hour on days 1-5.
Biological: wild-type reovirus
Given IV
Other Name: REOLYSIN
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol

Detailed Description:

PRIMARY OBJECTIVES:

I. To estimate the progression-free survival hazard ratio of the combination of weekly paclitaxel with Reolysin (wild-type reovirus) to weekly paclitaxel alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.

II. To determine the frequency and severity of adverse events associated with treatment with weekly paclitaxel alone and weekly paclitaxel with REOLYSIN as assessed by CTCAE.

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival and overall survival of patients treated with weekly paclitaxel alone and weekly paclitaxel with REOLYSIN.

II. To estimate (and compare) the proportion of patients who respond to the regimen on each arm of the study (according to RECIST 1.1 with measurable patients and by CA-125 for those patients with detectible disease only).

III. To characterize and compare progression-free survival and overall survival in patients with measurable disease (RECIST 1.1 criteria) and patients with detectable (non-measurable) disease.

OUTLINE: This is a multicenter study. Patients are stratified according to their platinum-free interval (=< 182 days vs > 182 days) and measurable disease status (measurable vs non-measurable or detectable). Patients are randomized to 1 of 2 treatment arms

ARM I: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15.

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

In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

  Eligibility

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

Inclusion Criteria:

  • 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 CT, 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 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 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 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
  • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic agents (biologic/targeted) or extended therapy administered after surgical or non-surgical assessment; if patients were treated with paclitaxel for their primary disease, this can have been given weekly or every 3 weeks
  • Patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease, with no more than 1 non-platinum, non-taxane regimen; treatment with weekly paclitaxel for recurrent or persistent disease is NOT allowed
  • Patients are allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted) therapy as part of their primary treatment regimen; patients are allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted) therapy as part of their treatment for recurrent or persistent disease and/or as treatment for recurrent or persistent disease; if non-cytotoxic (biologic/targeted) therapy is given alone (i.e., not in combination with cytotoxic chemotherapy) it will NOT count as a prior regimen

    • For the purposes of this study, Poly (ADP-ribose) polymerase (PARP) inhibitors will NOT count as a prior regimen when given alone (i.e., not in combination with cytotoxic chemotherapy)
  • Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Hemoglobin greater than or equal to 9 g/dL
  • Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
  • Bilirubin less than or equal to 1.5 x ULN
  • SGOT less than or equal to 3 x ULN and alkaline phosphatase less than or equal to 2.5 x ULN
  • Neuropathy (sensory and motor) less than or equal to grade 1
  • Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; (pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects)
  • Patients must have signed an approved informed consent and authorization permitting the release of personal health information
  • Patients must meet pre-entry requirements as specified
  • Patients must be able to avoid direct contact with severely immune-compromised individuals such as patients who have had a recent bone-marrow or organ transplant or patients with AIDS; contact should be avoided on the days of REOLYSIN treatment and for the 2 days following REOLYSIN treatment
  • Patients must be able to avoid direct contact with pregnant or nursing women and infants while receiving REOLYSIN; contact should be avoided on the days of REOLYSIN treatment and for the 2 days following REOLYSIN treatment

Exclusion Criteria:

  • 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 FIGO Grade 3 lesions
  • Patients with known 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 because of the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel and Reolysin, 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199263

  Show 35 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: David Cohn Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01199263     History of Changes
Other Study ID Numbers: NCI-2011-02654, NCI-2011-02654, CDR0000684693, GOG-0186H, GOG-0186H, U10CA027469
Study First Received: September 9, 2010
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014