Progressive disease is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Unequivocal progression of existing non-target lesions, other than pleural effusions without cytological proof of neoplastic origin, in the opinion of the treating physician within 8 weeks of study entry is also considered increasing disease (in this circumstance an explanation must be provided). In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in the LD is required.

Overall Survival is the observed length of life from entry into the study to death or the date of last contact

-Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.

• The FACT-O questionnaire consists of a Physical Well-Being Section, Social/Family Well-Being Section, Emotional Well-Being Section, Functional Well-Being Section, and Additional Concerns Section
• Answers range from "Not at all" to "Very Much" with 0 = not at all and 4 = very much

• Progression is defined as one of the following:

  • Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 ≥ twice the upper limit of normal on two occasions at least one week apart
  • Patients with elevated CA-125 pretreatment which never normalizes must show evidence of CA-125 ≥ 2 times the nadir value OR > 50% increase from the nadir on two occasions at least one week apart,
  • Patients with CA-125 in the normal range pretreatment must show evidence of CA-125 ≥ two times the upper limit of normal on two occasions at least one week apart.

• Complete response is defined as a CA-125 value <13 confirmed on two occasions at least 2 weeks apart.

• Partial Response is defined as a reduction of at least 50% from the original elevated CA-125 value (original value must have been > 50), confirmed on two occasions at least 2 weeks apart.

• Stable Disease is defined as not meeting one of the above criteria.

Progressive disease is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Unequivocal progression of existing non-target lesions, other than pleural effusions without cytological proof of neoplastic origin, in the opinion of the treating physician within 8 weeks of study entry is also considered increasing disease (in this circumstance an explanation must be provided). In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in the LD is required.

The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.

Overall Survival is the observed length of life from entry into the study to death or the date of last contact

The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.

-Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.

The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.

• The FACT-O questionnaire consists of a Physical Well-Being Section, Social/Family Well-Being Section, Emotional Well-Being Section, Functional Well-Being Section, and Additional Concerns Section
• Answers range from "Not at all" to "Very Much" with 0 = not at all and 4 = very much

The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.