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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median Time to Tumor Progression

Outcome 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

Outcome Time Frame:

Date on study to the date of measured progressive disease, every 2 cycles (2 months)

Safety Issue:

No

Principal Investigator

Marta Crispens, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

VICC GYN 0288

NCT ID:

NCT00653328

Start Date:

May 2003

Completion Date:

March 2009

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • peritoneal cavity cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Adenocarcinoma, Papillary
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Jackson-Madison County Hospital Jackson, Tennessee  38301
St. Thomas Health Services Nashville, Tennessee  37205
Kentuckiana Cancer Institute Louisville, Kentucky  40202
The Jones Clinic Germantown, Tennessee  38138
Central Georgia Hematology Oncology Associates, P.C. Macon, Georgia