Clinical trial NCT00316173: Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Neoplasms, Ovarian
Keywords: HYCAMTIN
ovarian cancer
recurrent
relapsed
carboplatin
topotecan
potentially platinum-sensitive
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-20
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: 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:
measure: Time to Response
timeFrame: From start of treatment to evidence of PR or CR (up to 39.3 weeks)
measure: Duration of Response
timeFrame: From time of PR or CR to disease progression/death (up to 56.0 weeks)
measure: Progression-free Survival
timeFrame: From start of treatment to disease progression/death (up to 67.7 weeks)
measure: 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).
measure: The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125)
timeFrame: Baseline to end of study (up to 54.7 weeks).
measure: Time to Disease Progression
timeFrame: From start of treatment to disease progression/death
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Orange
country: United States
facility: GSK Investigational Site
state: California
city: Poway
country: United States
facility: GSK Investigational Site
state: California
city: Stanford
country: United States
facility: GSK Investigational Site
state: California
city: New Haven
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: South Bend
country: United States
facility: GSK Investigational Site
state: Indiana
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Brightwaters
country: United States
facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Mayfield Heights
country: United States
facility: GSK Investigational Site
state: Ohio
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Rose PG, Monk BJ, Provencher D, Hartney J, Legenne P, Lane S. 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 cancer. Gynecol Oncol. 2011 Jan;120(1):38-42. doi: 10.1016/j.ygyno.2010.10.011. Epub 2010 Nov 5.