Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer
Condition: Ovarian Cancer; Neoplasms, Ovarian
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Hypersensitivity
Intervention: topotecan; CARBOPLATIN
Intervention description: HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1; HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1
Intervention MeSH terms: Carboplatin; Topotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HYCAMTIN; ovarian cancer; recurrent; relapsed; carboplatin; topotecan; potentially platinum-sensitive

Summary:

      This study was designed to find the most effective and safest doses of both HYCAMTIN and
      CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow
      researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subject must have baseline laboratory values as follows:

          -  Hemoglobin 9.0 g/dL

          -  Neutrophils 1,500/mm3

          -  Platelets 100,000/mm3

          -  Creatinine 1.5 mg/dL ( 133 mol/l) or creatinine clearance 60 mL/min

          -  Serum bilirubin < 2.0 mg/dL (< 35 umol/L)

          -  SGOT/AST, SGPT/ALT and alkaline phosphatase < 2 times ULN if liver metastases are
             absent by abdominal CT or MRI or < 5 times ULN if liver metastases are present

          -  Subject is allowed to have received, but is not required to have received, one
             additional prior non-cytotoxic regimen for management of recurrent or persistent
             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

          -  Subject is female 18 years of age with an ECOG Performance Status of 0, 1 or 2

          -  Subject has recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
             which was histologically confirmed at the time of the primary diagnosis

          -  Subject has received one prior platinum-based chemotherapeutic regimen (containing
             either carboplatin or cisplatin) for the treatment of primary disease. Consolidation
             chemotherapy is not permitted

          -  Subject's disease is considered potentially platinum-sensitive (i.e., have had a
             platinum-free interval following complete response to carboplatin or cisplatin of
             greater than 6 months)

          -  Subject must have at least one measurable lesion as determined by diagnostic studies
             including CT or MRI or physical exam. Measurable disease must be accurately measured
             in at least one dimension (longest dimension to be recorded). Each lesion must be 20
             mm in their longest dimension when measured by conventional techniques, including
             palpation, plain X-ray, CT and MRI, or 10 mm when measured by spiral CT. Palpable
             tumor masses that cannot be evaluated radiologically must have 2 diameters 20 mm. An
             attempt to document lesion size by ultrasound should be undertaken for palpable
             lesions not visualized on CT (or MRI).

          -  The same diagnostic imaging method used to evaluate disease must be used throughout
             the study to evaluate lesions consistently

          -  Stable blood, liver and renal functions.

          -  Subjects of child-bearing potential must be practicing adequate contraception (e.g.
             oral contraceptives, diaphragm plus spermicide, or IUD) for at least 3 months prior to
             study start. The same contraceptive method should be used throughout the study and
             continue for at least 4 weeks after the end of the study

        Exclusion criteria:

          -  Pregnant or lactating.

          -  Subject has received more than 1 prior chemotherapy regimen or a history of
             consolidation cytotoxic chemotherapy

          -  Subject has concomitant or history of previous malignancies, with the exception of
             adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,
             or other cancer from which the subject has been disease-free for 5 years

          -  Subject has brain metastases as documented by CT or MRI. Note: Asymptomatic subjects
             do not require CT or MRI to rule out brain metastases

          -  Received previous treatment with HYCAMTIN.

          -  Subject has received an investigational agent within 30 days or 5 half-lives
             (whichever is longer) prior to study entry

          -  Received prior radiation therapy for ovarian cancer