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Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD) (ZACFAST)

This study has been terminated.
(Lack of efficacy)
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014