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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
atrasentan hydrochloride
doxil
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

Exclusion Criteria:

Not specified

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

Sites / Locations

  • Central Georgia Hematology Oncology Associates, P.C.
  • Kentuckiana Cancer Institute
  • The Jones Clinic
  • Jackson-Madison County Hospital
  • St. Thomas Health Services
  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic Intervention

Arm Description

Outcomes

Primary Outcome Measures

Median Time to Tumor Progression
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

Number of Patients With Objective Response
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
Overall Survival
Number of Patients With Worst Grade Toxicities
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

Full Information

First Posted
April 3, 2008
Last Updated
May 16, 2012
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00653328
Brief Title
Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Abbott (drug manufacturer) discontinued manufacture of ABT-627
Study Start Date
May 2003 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 Doxil 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Intervention
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
atrasentan hydrochloride
Other Intervention Name(s)
ABT-627, Xinlay
Intervention Description
Atrasentan 10 mg orally everyday continuously beginning on Day 1.
Intervention Type
Drug
Intervention Name(s)
doxil
Other Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride (Doxil)
Intervention Description
50 mg/m2 intravenously every 28 days
Primary Outcome Measure Information:
Title
Median Time to Tumor Progression
Description
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
Time Frame
Date on study to the date of measured progressive disease, every 2 cycles (2 months)
Secondary Outcome Measure Information:
Title
Number of Patients With Objective Response
Description
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
Time Frame
At month 2 and monthly thereafter to cessation of treatment
Title
Overall Survival
Time Frame
Date on study to date of death from any cause
Title
Number of Patients With Worst Grade Toxicities
Description
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
Time Frame
Weekly for 2 weeks, then monthly for 5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 Exclusion Criteria: Not specified 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Crispens, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Georgia Hematology Oncology Associates, P.C.
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Kentuckiana Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
The Jones Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Jackson-Madison County Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
383013956
Country
United States
Facility Name
St. Thomas Health Services
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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