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Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00653328
Recruitment Status : Terminated (Abbott (drug manufacturer) discontinued manufacture of ABT-627)
First Posted : April 4, 2008
Results First Posted : April 21, 2011
Last Update Posted : May 23, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Marta Crispens, MD, Vanderbilt-Ingram Cancer Center

Brief Summary:

RATIONALE: There is emerging data to suggest that the optimal use of angiogenesis inhibitors may be in combination with chemotherapy. The optimal use of atrasentan may be in combination with chemotherapy in women with relapsed and refractory ovarian cancer,fallopian tube cancer, and peritoneal serous papillary adenocarcinoma. Due to its manageable toxicity profile, ease of administration, and activity in both platinum sensitive as well as platinum-resistant patients, Doxil has become the 2nd-line treatment of choice for women with advanced stage ovarian cancer that has progressed following 1st-line platinum/taxane therapy.

PURPOSE: To determine if a treatment combination of atrasentan + Doxil is an effective 2nd line treatment in patients with recurrent ovarian cancer, fallopian tube cancer, or peritoneal cancer.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Drug: atrasentan hydrochloride Drug: doxil Phase 2

Detailed Description:



  • 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 Doxil and atrasentan hydrochloride.


  • 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 will be administered Doxil 50 mg/m2 intravenous every 28 days and take atrasentan 10 mg orally everyday continuously beginning on Day 1. Patients will continue Doxil + atrasentan 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Atrasentan (ABT-627) Plus DOXIL in Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Serous Papillary Adenocarcinoma Following Platinum + Taxane Therapy
Study Start Date : May 2003
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: Therapeutic Intervention Drug: atrasentan hydrochloride
Atrasentan 10 mg orally everyday continuously beginning on Day 1.
Other Names:
  • ABT-627
  • Xinlay

Drug: doxil
50 mg/m2 intravenously every 28 days
Other Name: pegylated liposomal doxorubicin hydrochloride (Doxil)

Primary Outcome Measures :
  1. Median Time to Tumor Progression [ Time Frame: Date on study to the date of measured progressive disease, every 2 cycles (2 months) ]
    Tumor progression is determined by appropriate imaging techniques according to RECIST criteria or by CA-125 serum level >=2x baseline and >=70 IU/ml, confirmed by a second determination at least 28 days after the first determination

Secondary Outcome Measures :
  1. Number of Patients With Objective Response [ Time Frame: At month 2 and monthly thereafter to cessation of treatment ]

    Patient response to treatment:

    Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started, or appearance of >= 1 new lesions, and/or 2x CA-125 levels to >=70 IU/ml, confirmed by second measurement after 28 days Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD

  2. Overall Survival [ Time Frame: Date on study to date of death from any cause ]
  3. Number of Patients With Worst Grade Toxicities [ Time Frame: Weekly for 2 weeks, then monthly for 5 months ]
    Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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


  • 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

Exclusion Criteria:

Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00653328

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United States, Georgia
Central Georgia Hematology Oncology Associates, P.C.
Macon, Georgia, United States, 31201
United States, Kentucky
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Tennessee
The Jones Clinic
Germantown, Tennessee, United States, 38138
Jackson-Madison County Hospital
Jackson, Tennessee, United States, 383013956
St. Thomas Health Services
Nashville, Tennessee, United States, 37205
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Marta Crispens, MD Vanderbilt-Ingram Cancer Center
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Responsible Party: Marta Crispens, MD, Associate Professor; Gynecological Oncologist, Vanderbilt-Ingram Cancer Center Identifier: NCT00653328    
Other Study ID Numbers: VICC GYN 0288
VU-VICC-GYN-0288 ( Other Identifier: Vanderbilt-Ingram Cancer Center )
First Posted: April 4, 2008    Key Record Dates
Results First Posted: April 21, 2011
Last Update Posted: May 23, 2012
Last Verified: May 2012
Keywords provided by Marta Crispens, MD, Vanderbilt-Ingram Cancer Center:
recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Adenocarcinoma, Papillary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists