Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD)

Ovarian Cancer Clinical Trial

— ZACFAST  

Official title:

Addition of Vandetanib to Standard Therapy (Pegliposomal Doxorubicin) in Patients With Recurrent Ovarian Cancer. A Multicentre Phase I / Randomized Phase II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00862836
• Other study ID #: D4200C00083
• Secondary ID: EUDRACT no 2008-
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: March 16, 2009
• Last updated: September 11, 2012
• Start date: April 2009
• Est. completion date: September 2010

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in 70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national centers will participate in phase I of the study. If the starting criteria for phase II of the study are met at the end of phase I, a total of approximately 20 national centers will participate in phase II of the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histopathologically documented invasive epithelial ovarian carcinoma, cancer of the fallopian tube or the peritoneum refractory to platinum-based chemotherapy or with partially platinum sensitive disease.

• Planned therapy with pegylated liposomal doxorubicin 50 mg/m² for recurrent platinum-refractory ovarian cancer.

• Patients with a progression-free-interval of 6 to 12 months after platinum-based chemotherapy are only eligible if a further course of platinum-based combination chemotherapy is not possible as judged by the investigator(s).

• Patients must have received at least one previous platinum- and taxane-based chemotherapy regimen.

Exclusion Criteria:

• Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days

• Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes or induce CYP3A4 function

• Treatment with mouse-antibodies in patients with evaluable disease and CA-125 progressive disease in the last 3 months. These patients are only eligible in case of measurable disease according to RECIST or cytological/histological proven relapse

• More than two prior lines of chemotherapy.

• Any chemotherapy or other systemic anti-cancer therapy within four weeks prior to randomization.

• Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy

Study Design

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Vandetanib
100mg doses orally, once daily

Locations

Country	Name	City	State
Germany	Research Site	Berlin
Germany	Research Site	Essen	Nordrhein-Westfalen
Germany	Research Site	Kiel	Schleswig-Holstein
Germany	Research Site	Ulm	Baden-Württemberg
Germany	Research Site	Wiesbaden	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	AGO Study Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).	Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3)	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Yes
Primary	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.	Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Yes
Primary	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.	Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening)	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Yes
Primary	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.	Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening).	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Yes
Primary	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3.	Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake)	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Yes
Primary	Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4.	Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).	From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.	Yes
Secondary	Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS).	Progression Free Survival: Progression is defined using RECIST, as a measurable increase of at least 20% in the sum of longest diameters of target lesions or uneqiuvocal progression of non-target lesions, or the appearance of new lesions, since baseline.	From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.	No
Secondary	Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS).	Median overall survival (OS)	From date of registration (Informed Consent Form completed) until the date of death.	No