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Fallopian Tube CancerPhase 2NCT00653328

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

A Phase 2 study testing atrasentan hydrochloride and doxil in people with Fallopian Tube Cancer and Ovarian Cancer, run by Vanderbilt-Ingram Cancer Center at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
atrasentan hydrochloride and doxil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
6 sitesUnited States
Study dates
May 2003to Mar 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 20Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • The Jones Clinic

    Germantown, Tennessee, 38138

  • Jackson-Madison County Hospital

    Jackson, Tennessee, 383013956

  • Kentuckiana Cancer Institute

    Louisville, Kentucky, 40202

  • Central Georgia Hematology Oncology Associates, P.C.

    Macon, Georgia, 31201

  • St. Thomas Health Services

    Nashville, Tennessee, 37205

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
atrasentan hydrochloride, doxil
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, peritoneal cavity cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • atrasentan hydrochlorideDrug

    Also called ABT-627, Xinlay

    Atrasentan 10 mg orally everyday continuously beginning on Day 1.

  • doxilDrug

    Also called pegylated liposomal doxorubicin hydrochloride (Doxil)

    50 mg/m2 intravenously every 28 days

Study groups in NCT00653328
Study groupRoleWhat they receive
Therapeutic InterventionExperimentalNot described
Receives: Drug: atrasentan hydrochloride; Drug: doxil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Time to Tumor Progression

    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

    Measured: Date on study to the date of measured progressive disease, every 2 cycles (2 months)

Secondary outcomes (3)

  1. Number of Patients With Objective Response

    Patient response to treatment:

    Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started, or appearance of >= 1 new lesions, and/or 2x CA-125 levels to >=70 IU/ml, confirmed by second measurement after 28 days Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD

    Measured: At month 2 and monthly thereafter to cessation of treatment

  2. Overall Survival

    Measured: Date on study to date of death from any cause

  3. Number of Patients With Worst Grade Toxicities

    Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria

    Measured: Weekly for 2 weeks, then monthly for 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2008 (estimated)
  2. Study startMay 2003
  3. Primary completionMar 2009
  4. Study completionMar 2009

Why it stopped: Abbott (drug manufacturer) discontinued manufacture of ABT-627

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00653328
Sponsor's protocol ID
VICC GYN 0288
Other IDs
VU-VICC-GYN-0288, VU-VICC-020947
Status last verified
May 2012
First submitted
3 Apr 2008
Last updated
23 May 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing atrasentan hydrochloride and doxil in people with Fallopian Tube Cancer and Ovarian Cancer, run by Vanderbilt-Ingram Cancer Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Time to Tumor Progression (time frame: Date on study to the date of measured progressive disease, every 2 cycles (2 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00653328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2012.

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