Patients with recurrent ovarian, fallopian tube, or primary peritoneal cancers. MedDRA version: 9.1 Level: LLT Classification code 10066697 Term: Ovarian cancer recurrent
Conditions
Interventions
Trade Name: Hycamtin
Product Name: Topotecan
Pharmaceutical Form: Powder for infusion*
Current Sponsor code: 609699
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concen
Sponsors
Gynecologic Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients must have recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic confirmation of the original primary tumor is required. - All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be = 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or = 10 mm when measured by spiral CT. - Patients must have at least one “target lesion” to be used to assess response on this protocol as defined by RECIST (Section 8.1). Tumors within a previously irradiated field will be designated as “non-target” lesions. - 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 for the same patient population. - Patients must have a GOG Performance Status of 0, 1, or 2. - Recovery from effects of recent surgery, radiotherapy, or chemotherapy Patients should be free of active infection requiring antibiotics. 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 biological and immunologic agents, must be discontinued at least three weeks prior to registration. - Prior therapy 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 high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment. Patients who have NOT received prior therapy with paclitaxel may receive a second regimen that includes paclitaxel. Patients must have NOT received any additional cytotoxic chemotherapy for management of recurrent disease, including retreatment with initial chemotherapy regimens. (Note: Optimal evaluation of the safety and efficacy of new chemotherapy regimens is best performed in patients with minimal prior therapy. Non-investigational therapy, such as retreatment with platinum and/or paclitaxel, is non-curative in the setting of recurrent disease, and can generally be safely administered to patients following participation in a phase II trial). Patients are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for management of recurrent disease according to the following definition: + Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction. Patients must be considered platinum sensitive according to standard GOG criteria, i.e., have had a platinum-free interval without clinical evidence of progressive disease following response to platinum of greater than 6 months. (Note: any non-platinum maintenance or consolidation therapy is not included in calculation of the platinum-free interval). - Patients must have adequate: Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, equivalent to Common Toxicity Criteria (CTCAE v3.0) grade 1. Platelets greater than or equal to 100,000/mcl. (01/15/2006) Renal function: Creatinine less than or equal to 1.5 x i
Exclusion criteria
Exclusion criteria: - Patients who have received prior therapy with topotecan, either as single agent therapy or in combination with other chemotherapeutic drugs. - Patients who have received radiation to more than 25% of marrow-bearing areas. - Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the anti-tumor activity of Topotecan administered on a weekly schedule with the frequency and duration of tumor responses in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancers. To determine the nature and degree of toxicity of this regimen in this cohort of patients;Secondary Objective: To determine the duration of progression-free survival and overall survival in this patient population treated with weekly Topotecan. To determine the effects of prognostic variables: initial performance status, age, and mucinous (or clear cell) histology. ;Primary end point(s): Parameters of Response – GOG RECIST Criteria - Measurable disease - Baseline documentation of “Target” and “Non-Target” lesions - Best Response - Complete Response - Partial Response - Increasing Disease - Symptomatic deterioration - Stable Disease - Inevaluable for response - Progression (measurable disease studies) - Recurrence (non-measurable disease studies). - Survival. - Progression-Free Survival (measurable disease studies) - Recurrence-Free Survival (non-measurable disease studies). - Subjective Parameters including performance status, specific symptoms, and side effects. | — |
Countries
Spain
Outcome results
None listed