Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer

Study Overview
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Brief Summary
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The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.

Detailed Description
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This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).

Official Title
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Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

Conditions
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Ovarian Neoplasms

Intervention / Treatment
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* Drug: Telcyta
* Drug: Liposomal Doxorubicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are a woman 18 years of age or older Have histologically or cytologically confirmed epithelial cancer or primary peritoneal cancer Have platinum refractory or resistant cancer Measurable disease according to radiographic RECIST criteria progression Exclusion Criteria: Had treatment with first-line chemotherapy other than a platinum-containing regimen Have clinically significant cardiac disease Have any sign of intestinal obstruction interfering with nutrition Are pregnant or lactating Had prior treatment with liposomal doxorubicin Had prior treatment with Telcyta

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telcyta + Liposomal Doxorubicin<br>Telcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle | Drug: Telcyta<br>* Day 1 of 28 day Cycle.<br>* Other names: canfosfamide;Drug: Liposomal Doxorubicin<br>* Day 1 of 28 Day Cycle. 50 mg/m2<br>* Other names: Caelyx;|
| Active Comparator: Liposomal Doxorubicin<br>Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle | Drug: Liposomal Doxorubicin<br>* Day 1 of 28 Day Cycle. 50 mg/m2<br>* Other names: Caelyx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin |  | Once 244 planned pts. received at least 2 cycles of study treatment(s) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate and compare the safety profile of each treatment arm |  | Any patient who received 1 dose of study treatment(s) will be evaluable for safety. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovary