Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer

Neoplasms, Ovarian

Treatments

Drug: CARBOPLATIN

Drug: topotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00316173

104864/902

Details and patient eligibility

About

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.

Enrollment

77 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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