Clinical trial NCT00653328: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-04
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Median Time to Tumor Progression
timeFrame: Date on study to the date of measured progressive disease, every 2 cycles (2 months)
Secondary outcomes:
measure: Number of Patients With Objective Response
timeFrame: At month 2 and monthly thereafter to cessation of treatment
measure: Overall Survival
timeFrame: Date on study to date of death from any cause
measure: Number of Patients With Worst Grade Toxicities
timeFrame: Weekly for 2 weeks, then monthly for 5 months
Other outcomes:
Locations:
city: Macon
country: United States
facility: Central Georgia Hematology Oncology Associates, P.C.
state: Georgia
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute
state: Kentucky
city: Germantown
country: United States
facility: The Jones Clinic
state: Tennessee
city: Jackson
country: United States
facility: Jackson-Madison County Hospital
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Health Services
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Marta Crispens, MD
role: PRINCIPAL_INVESTIGATOR
References: