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

NCT ID: NCT00653328

Last Updated: 2012-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2009-03-31

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapeutic Intervention

Group Type: EXPERIMENTAL

atrasentan hydrochloride

Intervention Type: DRUG

Atrasentan 10 mg orally everyday continuously beginning on Day 1.

doxil

Intervention Type: DRUG

50 mg/m2 intravenously every 28 days

Interventions

atrasentan hydrochloride

Atrasentan 10 mg orally everyday continuously beginning on Day 1.

Intervention Type: DRUG

doxil

50 mg/m2 intravenously every 28 days

Intervention Type: DRUG

Other Intervention Names

ABT-627; Xinlay; pegylated liposomal doxorubicin hydrochloride (Doxil)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Marta Crispens, MD

Associate Professor; Gynecological Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marta Crispens, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Locations

Central Georgia Hematology Oncology Associates, P.C.

Macon, Georgia, United States

Kentuckiana Cancer Institute

Louisville, Kentucky, United States

The Jones Clinic

Germantown, Tennessee, United States

Jackson-Madison County Hospital

Jackson, Tennessee, United States

St. Thomas Health Services

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

VU-VICC-GYN-0288

Identifier Type: OTHER

Identifier Source: secondary_id

VU-VICC-020947

Identifier Type: -

Identifier Source: secondary_id

VICC GYN 0288

Identifier Type: -

Identifier Source: org_study_id