Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

Telik

Status and phase: Terminated; Phase 3

Conditions: Ovarian Neoplasms

Treatments: Drug: Telcyta; Drug: Liposomal Doxorubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00350948

TLK286.3025

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 244 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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244 participants in 2 patient groups

Telcyta + Liposomal Doxorubicin

Experimental group

Description:

Telcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle

Treatment:

Drug: Liposomal Doxorubicin

Drug: Telcyta

Liposomal Doxorubicin

Active Comparator group

Description:

Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle

Treatment:

Drug: Liposomal Doxorubicin