Comparison of Quality of Life in Patients With Platinum-sensitive Recurrent Ovarian, Fallopian Tube and Peritoneal Cancer When Treated With Treatment With Trabectedin/PLD or Standard Platinum-based Therapy

NCT00170573 Phase 2 COMPLETED Results posted

Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life

Details

Lead sponsor	North Eastern German Society of Gynaecological Oncology
Phase	Phase 2
Status	COMPLETED
Enrolment	77
Start date	2001-09
Completion	2010-08

Conditions

• Ovarian Cancer

Interventions

• Caelyx

Primary outcomes

• Occurrence of Palmar-plantar Erythrodysesthesia (PPE) — through study completion, an average of 18 months
  The outcome will be measured by number of participants with reported skin toxicity PPE of CTC (Common Toxicity Criteria)-Grade I / II / III / IV. Grade I - Dysesthesia/paraesthesia tingling of hands and feet; Grade II - Discomfort in holding objects and upon walking, painless swelling and erythema; Grade III - painful erythema and swelling of palms and soles, periungual erythema and swelling; Grade IV - Desquamation, ulceration, blistering, severe pain