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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 CenterNashville, Tennessee  37232-6838
Jackson-Madison County HospitalJackson, Tennessee  38301
St. Thomas Health ServicesNashville, Tennessee  37205
Kentuckiana Cancer InstituteLouisville, Kentucky  40202
The Jones ClinicGermantown, Tennessee  38138
Central Georgia Hematology Oncology Associates, P.C.Macon, Georgia