Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma
Condition: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Adenocarcinoma; Fallopian Tube Neoplasms; Adenocarcinoma, Papillary
Intervention: atrasentan hydrochloride; doxil
Intervention description: Atrasentan 10 mg orally everyday continuously beginning on Day 1.; 50 mg/m2 intravenously every 28 days
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Atrasentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent ovarian epithelial cancer; fallopian tube cancer; peritoneal cavity cancer

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.
    

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