GOG186H: 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
The study plan is a single stage randomized phase ii clinical trial (with an interim futility analysis at approximately 50% of the information time), assigning patients to one of two arms with equal probability. Patients will be stratified according to their platinum-free interval PFi (those with a PFi [LessThanorequalTo] 182 days versus those with PFi [Greater Than] 182 days) and measurable disease status (measurable versus non-measurable or [Quote]detectable[Quote] disease).
Patients will be randomized into one of the following 2 groups.
Regimen 1: Paclitaxel 80 mg/m2 iV over 1 hour days 1, 8, 15 every 28 days
Regimen 2: Paclitaxel 80 mg/m2 iV over 1 hour days 1, 8, 15 every 28 days, with ReoLYSin[RegisteredTM] 3x1010 TCiD50 /day iV over 1 hr on days 1-5 every 28 days.
one cycle equals 28 days. if side effects are not severe, a patient may remain on study indefinitely until evidence of disease progression or unacceptable toxicity.
Patients should not be treated with acetaminophen or acetaminophen-containing medications while on ReoLYSin[RegisteredTM] therapy.
3.11 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.
3.12 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.
3.13 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 (Section 8.1). Tumors within a previously irradiated field will be designated as
* lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
3.14 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.
3.15 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.
3.16 Recovery from effects of recent surgery, radiotherapy, or chemotherapy:
3.161 Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated UTI).
3.162 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.
3.163 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. (02/14/11)
3.17 Prior therapy
3.171 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. (02/14/11)
3.172 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. (02/14/11)
3.173 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). (02/14/11)
3.174 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.
3.18 Patients must have adequate:
3.181 Bone marrow function:
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.
3.182 Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN).
3.183 Hepatic function: 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.
3.184 Neurologic function: Neuropathy (sensory and motor) less than or equal to grade 1.
3.19 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.)
3.110 Patients must have signed an approved informed consent and authorization permitting the release of personal health information.
3.111 Patients must meet pre-entry requirements as specified in section 7.0.
3.112 Patients must be >= 18 years of age.
3.113 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(RegisteredTM) treatment and for the 2 days following REOLYSIN(RegisteredTM) treatment. (12/10/2012)
3.114 Patients must be able to avoid direct contact with pregnant or nursing women and infants while receiving REOLYSIN(RegisteredTM). Contact should be avoided on the days of REOLYSIN(RegisteredTM) treatment and for the 2 days following REOLYSIN(RegisteredTM) treatment. (12/10/2012)