Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD) (ZACFAST)
This study has been terminated.
(Lack of efficacy)
Sponsor:
AstraZeneca
Collaborator:
AGO Study Group
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00862836
First received: March 16, 2009
Last updated: September 11, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: Vandetanib |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Addition of Vandetanib to Standard Therapy (Pegliposomal Doxorubicin) in Patients With Recurrent Ovarian Cancer. A Multicentre Phase I / Randomized Phase II Study |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). [ Time Frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. ] [ Designated as safety issue: Yes ]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)
- Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. [ Time Frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. ] [ Designated as safety issue: Yes ]Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).
- 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. [ Time Frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. ] [ Designated as safety issue: Yes ]Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening)
- 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. [ Time Frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. ] [ Designated as safety issue: Yes ]Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening).
- 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. [ Time Frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. ] [ Designated as safety issue: Yes ]Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake)
- 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. [ Time Frame: From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months. ] [ Designated as safety issue: Yes ]Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).
Secondary Outcome Measures:
- 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). [ Time Frame: 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. ] [ Designated as safety issue: No ]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.
- 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). [ Time Frame: From date of registration (Informed Consent Form completed) until the date of death. ] [ Designated as safety issue: No ]Median overall survival (OS)
| Enrollment: | 15 |
| Study Start Date: | April 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Vandetanib added to standard therapy (pegliposomal doxorubicin)
|
Drug: Vandetanib
100mg doses orally, once daily
Other Name: Zactima
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862836
Locations
| Germany | |
| Research Site | |
| Ulm, Baden-Württemberg, Germany | |
| Research Site | |
| Wiesbaden, Hessen, Germany | |
| Research Site | |
| Essen, Nordrhein-Westfalen, Germany | |
| Research Site | |
| Kiel, Schleswig-Holstein, Germany | |
| Research Site | |
| Berlin, Germany | |
Sponsors and Collaborators
AstraZeneca
AGO Study Group
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00862836 History of Changes |
| Other Study ID Numbers: | D4200C00083, EUDRACT no 2008-0005557-38 |
| Study First Received: | March 16, 2009 |
| Results First Received: | November 2, 2011 |
| Last Updated: | September 11, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by AstraZeneca:
|
ZD6474 Vandetanib Zactima Ovarian Cancer |
Phase I Phase II Randomized Safety |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female |
Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013