Last updated: 11/03/2018 01:18:13
Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 every 21 days) HYCAMTIN in Combination with Carboplatin (Day 1 every 21 days) as Second-Line Therapy in Subjects with Potentially Platinum-Sensitive Relapsed Ovarian Cancer
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with the indicated response
Timeframe: From start of treatment to evidence of CR or PR (up to 39.3 weeks).
Secondary outcomes:
Time to response
Timeframe: From start of treatment to evidence of PR or CR (up to 39.3 weeks)
Duration of response
Timeframe: From time of PR or CR to disease progression/death (up to 56.0 weeks)
Progression-free survival
Timeframe: From start of treatment to disease progression/death (up to 67.7 weeks)
Number of participants who died from the start of treatment to follow-up
Timeframe: From start of treatment to death (up to 110.4 weeks).
The number of participants classified as responders in cancer antigen 125 (CA-125)
Timeframe: Baseline to end of study (up to 54.7 weeks).
Time to disease progression
Timeframe: From start of treatment to disease progression/death
Interventions:
Drug: topotecan
Drug: CARBOPLATIN
Enrollment:
77
Observational study model:
Not applicable
Primary completion date:
2009-02-02
Time perspective:
Not applicable
Clinical publications:
Schwartz PE, Rose PG, Monk BJ, et al. An open-label, single arm, phase II study of IV weekly (days 1 and 8) topotecan in combination with carboplatin (day 1) every 21 days as second-line therapy in subjects with platinum sensitive relapsed ovarian cancer: First stage results. J Clin Oncol. 2008; 26 (May 20 suppl). Abstract 16518
Peter G. Rose MD, Bradley J. Monk MD, Diane Provencher MD, Jean Hartney, Philippe Legenne, Stephen Lane. An Open-label, Single-arm Phase II Study of Intravenous Weekly (Days 1 and 8) Topotecan in Combination with Carboplatin (Day 1) every 21 Days as Second-line Therapy in Patients with Platinum-sensitive Relapsed Ovarian CancerAn Open-label, Single-arm Phase II Study of Intravenous Weekly (Days 1 and 8) Topotecan in Combination with Carboplatin (Day 1) every 21 Days as Second-line Therapy in Patients with Platinum-sensitive Relapsed Ovarian Cancer. [Gynecol Oncol]. 2011;120:38-42.
Medical condition
Ovarian Cancer
Product
topotecan
Collaborators
Not applicable
Study date(s)
March 2005 to February 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Subject must have baseline laboratory values as follows:
- Hemoglobin 9.0 g/dL
- Pregnant or lactating.
- Subject has received more than 1 prior chemotherapy regimen or a history of consolidation cytotoxic chemotherapy
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44109-1998
98.0 miles (156.8 km) away from your location
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-02-02
Actual study completion date
2009-02-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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