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Atrasentan and Doxorubicin Hydrochloride Liposome as Second-Line Therapy in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00653328
  Purpose

RATIONALE: Drugs used in chemotherapy, such as atrasentan and doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying giving atrasentan together with doxorubicin hydrochloride liposome as second-line therapy to see how well it works in treating patients with recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: atrasentan hydrochloride
Drug: pegylated liposomal doxorubicin hydrochloride
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Atrasentan Atrasentan hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: A Phase II Study of Atrasentan (ABT-627) Plus Pegylated Liposomal Encapsulated Doxorubicin (DOXIL) in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Serous Papillary Adenocarcinoma Following Platinum + Taxane Therapy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to tumor progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity according to NCI Common Toxicity Criteria, Version 2.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2003
Estimated Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the median time to tumor progression in patients with recurrent ovarian epithelial cancer, fallopian tube adenocarcinoma, or peritoneal serous papillary adenocarcinoma treated with pegylated liposomal doxorubicin hydrochloride and atrasentan hydrochloride.

Secondary

  • To determine the objective response rate and survival of patients treated with this regimen.
  • To determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment with platinum-taxane (sensitive vs resistant).

Patients receive oral atrasentan hydrochloride once daily on days 1-28 and pegylated liposomal doxorubicin hydrochloride IV on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days and every 2 months thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma arising from the ovary, fallopian tubes, or peritoneum (i.e., peritoneal serous papillary adenocarcinoma)
  • Received prior treatment with either cisplatin or carboplatin in combination with paclitaxel or docetaxel as first-line chemotherapy
  • Radiographic evidence of progressive disease and/or a doubling of CA-125 levels ≥ 70 IU/mL following first-line chemotherapy
  • Measurable disease as defined by RECIST criteria
  • No CNS metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/μL
  • Hemoglobin ≥ 9.5 g/dL
  • Platelets > 100,000/μL
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN if liver metastases are present)
  • LVEF ≥ 50% by MUGA
  • Not pregnant or nursing
  • Negative pregnancy test
  • Surgically sterile or must use effective contraception
  • No known HIV positivity or AIDS
  • No uncontrolled heart disease, diabetes, or other medical condition that would place the patient at unacceptably high risk for toxicity
  • No New York Heart Association class I-IV heart failure

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior toxicities to ≤ grade 1 by NCI-CTC Version 2 criteria
  • No other prior systemic therapies for this cancer except cisplatin or carboplatin in combination with paclitaxel or docetaxel as first-line chemotherapy
  • More than 4 weeks since prior chemotherapy
  • No concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653328

Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Mace L. Rothenberg, MD, FACP Vanderbilt-Ingram Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000584698, VU-VICC-GYN-0288, VU-VICC-020947
Study First Received: April 3, 2008
Last Updated: December 19, 2008
ClinicalTrials.gov Identifier: NCT00653328  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Ovarian cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Abdominal Neoplasms
Doxorubicin
Fallopian Tube Neoplasms
Recurrence
Fallopian Tube Diseases
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Fallopian tube cancer
Peritoneal Neoplasms
Adenocarcinoma
Taxane
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009