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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

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Neoplasms, Ovarian

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Trial Information

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

Inclusion 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With the Indicated Response

Outcome Description:

Overall response rate, as determined by radiologic evaluation (utilizing the World Health Organization [WHO] criteria and/or physical examination was measured. Complete response (CR: complete disappearance of all lesions), partial response (PR: >50% decrease in the measurements of the largest lesions with no appearance of new lesions), stable disease (SD: no change in tumor size for at least 8 weeks) and progressive disease (PD: >25% increase in measurements of lesions or appearance of new lesions).

Outcome Time Frame:

From start of treatment to evidence of CR or PR (up to 39.3 weeks).

Safety Issue:


Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Canada: Canadian Institutes of Health Research

Study ID:




Start Date:

March 2005

Completion Date:

March 2009

Related Keywords:

  • Ovarian Cancer
  • Neoplasms, Ovarian
  • ovarian cancer
  • recurrent
  • relapsed
  • carboplatin
  • topotecan
  • potentially platinum-sensitive
  • Neoplasms
  • Ovarian Neoplasms



GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteGreen Bay, Wisconsin  54301
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteHartford, Connecticut  06106
GSK Investigational SiteHenderson, Nevada  89014
GSK Investigational SiteSalt Lake City, Utah  84107
GSK Investigational SiteSeattle, Washington  98133