NCT00059618

Brief Summary

The goal of this clinical research study is to find the highest safe dose of PS-341 that can be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal, or fallopian tube cancer. Researchers also hope to find out if giving these drugs together will help shrink or slow the growth of tumors in patients who are considered resistant to platinum drugs. The safety of these drugs will also be studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 ovarian-cancer

Timeline
Completed

Started Apr 2003

Typical duration for phase_1 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2003

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

4 years

First QC Date

April 29, 2003

Last Update Submit

August 1, 2012

Conditions

Ovarian CancerPrimary Peritoneal CancerFallopian Tube Cancer

Keywords

Platinum ResistantTaxane ResistantOvarian CancerPrimary Peritoneal CancerFallopian Tube CancerBortezomibPS-341VelcadeLDP-341MLN341CarboplatinParaplatin

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of Bortezomib with Carboplatin Chemotherapy

    Assessed Day 21 of each 28 Day cycle, up to 4 cohorts for a total of 8 cycles

Study Arms (1)

Bortezomib

EXPERIMENTAL

PS-341 (Bortezomib) 0.8-1.5 mg/m\^2 IV push + Carboplatin (AUC 5) IV on Day 1 of each cycle, then Bortezomib alone on Days 4, 8 and 11 in each 28 day cycle.

Drug: PS-341 (Bortezomib)Drug: Carboplatin

Interventions

PS-341 (Bortezomib)DRUG

Starting dose 0.8 mg/m\^2 given by vein over 5-10 seconds Day 1, 4, 8 and 11 of 28 day cycle for 8 cycles.

Also known as: Velcade, LDP-341, MLN341
Bortezomib
CarboplatinDRUG

AUC 5 by vein administered over one hour Day 1 of 28 day cycle for 8 cycles.

Also known as: Paraplatin
Bortezomib

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have histologically-confirmed ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with advanced and/or metastatic disease. All patients must be considered platinum- and taxane- resistant.
  • Platinum resistance is defined as:
  • Progression of disease during platinum or taxane chemotherapy, or
  • Progression of disease within 6 months of completing platinum or taxane chemotherapy
  • Failure to achieve a complete response, with persistent macroscopic disease, after 6 cycles of chemotherapy, if the last two cycles had no measurable change in disease status
  • Patients may have had any number of prior chemotherapy regimens, except high dose chemotherapy an/or peripheral blood stem cell transplantation (high dose: higher than the standard doses of chemotherapy)
  • Patients must have measurable disease.
  • Zubrod performance status of \< 2.
  • Patients must give voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
  • Adequate liver, renal and bone marrow function, defined as:
  • Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L.
  • Platelets \> 100 x 10\^9/L
  • Total bilirubin \< 1.7 umol/L
  • Alanine transaminase (ALT) and aspartate transaminase (AST) \< 1.5 x Upper Limits of Normal (ULN)
  • Alkaline phosphatase \< 2.5 x ULN.
  • +1 more criteria

You may not qualify if:

  • Chemotherapy within four weeks of first course of PS-341. (Patients may have been on hormonal therapy).
  • Patients who previously received high-dose chemotherapy (higher than the standard doses of chemotherapy) and/or peripheral blood stem cell transplantation.
  • Radiation therapy within four weeks of enrollment (excepting palliative XRT).
  • Patients not recovered from toxic effects of previous chemotherapy, radiation therapy, or antibody therapy.
  • Patients with \> Grade 2 peripheral neuropathy.
  • Surgery within four weeks of study enrollment.
  • History of severe hypersensitivity reaction to carboplatin
  • Electrocardiographic evidence of acute ischemia or new conduction system abnormalities.
  • Myocardial infarction within six months of enrollment.
  • Patients with brain metastases or central nervous system disease as evidenced by clinical symptoms.
  • History of other malignancy, except nonmelanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off all therapy for that disease for a minimum of 5 years. Chemotherapy given for prior cancers will not exclude patients from participating in this study.
  • Patients with previously documented human immunodeficiency virus (HIV) infection. HIV-positive patients are excluded from the study based on theoretical concerns regarding the effect of PS-341 on certain aspects of immune function. NF-KB is a critical T cell activation protein (including through CD40L/CD 154 stimulation) and also is involved in cytokine production. Because PS 341 effectively blocks NF-KB and therefore could reduce or block the ability of T lymphocytes and other immune cells to fight HIV, PS-341 should not be administered to HIV-positive patients. Additional experiments in animal models are being conducted to better elucidate the effects of PS-341 on HIV.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Other serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
  • Patients who are pregnant, suspected to be pregnant, or breast-feeding.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

BortezomibCarboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoordination Complexes

Study Officials

  • Pedro T. Ramirez, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2003

First Posted

April 30, 2003

Study Start

April 1, 2003

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

US(1)