E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with recurrent ovarian, fallopian tube, or primary peritoneal cancers. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066697 |
E.1.2 | Term | Ovarian cancer recurrent |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 institutional upper limit normal (ULN), CTCAE v3.0 grade 1 and calculated creatinine clearance (CrCl) greater than to 40 mL/min using the Standard Cockroft and Gault formula only (Cockroft and Gault 1976). Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1). Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1. - 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 in section 7.0. - Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception. - Patients must be at least 18 years of age. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Patients will receive therapy until disease progression or intolerable toxicity intervenes. All patients will be followed until disease progression or study withdrawal. Following disease progression, patients will be monitored for delayed toxicity and survival for a period of 5 years with Q forms submitted to the GOG Statistical and Data Center, unless consent is withdrawn.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |