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

Vanderbilt University Medical Center

Status and phase

Terminated

Phase 2

Conditions

Fallopian Tube Cancer

Peritoneal Cavity Cancer

Ovarian Cancer

Treatments

Drug: doxil

Drug: atrasentan hydrochloride

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00653328

VICC GYN 0288

VU-VICC-020947

VU-VICC-GYN-0288 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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