NCT01175772

Brief Summary

Preclinical studies showed that metronomic chemotherapy can induce tumor regression secondary to apoptosis of the tumor blood vessels. This effect was increased by combining metronomic chemotherapy with anti-angiogenic drugs. Metronomic chemotherapy has already proved clinical effects too, especially on patients with breast or prostate carcinoma. This study is aimed to test the efficacy of an experimental metronomic chemotherapy regimen in a cohort of patients with ovarian cancer. Patients will receive the proposed regimen as maintenance treatment following response induction by the conventional maximal tolerated dose (MTD) regimen of Carboplatin and Paclitaxel. Our regimen will include Cytophosphan combined with two agents which are expected to act as indirect angiogenic inhibitors: (a) celecoxib, as a selective COX-2 inhibitor and (b) low-dose Methotrexate, as successfully practiced for suppressing the inflammatory manifestations of rheumatoid arthritis. All components of our regimen will be administered orally and continuously for one year based on the hypothesis that its anti-angiogenic properties will be able to suppress the recovery of residual disease, thus extending the time to progression (TTP), and possibly the overall survival as well.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

2.7 years

First QC Date

August 1, 2010

Last Update Submit

June 21, 2015

Conditions

Ovarian Carcinoma

Keywords

OvaryCarcinomaMaintenanceMetronomicChemotherapyTime to Progressionoverall survival

Outcome Measures

Primary Outcomes (1)

  • Time to Progression

    Median time to progression of the cohort will be compared with equivalent measure in the literature.

    18 months

Study Arms (1)

Metronomic Chemoterapy

EXPERIMENTAL

Maintenance Treatment for Ovary Carcinoma by Metronomic Chemotherapy

Drug: Cytophosphan, Celecoxib, Methotrexate

Interventions

Cytophosphan, Celecoxib, MethotrexateDRUG

Metronomic Chemotherapy as maintenance treatment for patients with Ovarian Cancer * Cytophosphan tab 50 mg -1x1 per day, continuous * Celecoxib tab 200 mg - 1x2 per day, continuous * Methotrexate tab 2.5 mg - 1x2 per day, 2 days weekly

Metronomic Chemoterapy

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic proof of papillary-serous ovarian cancer or 1ary peritoneal carcinomatosis.
  • Histological grade III.
  • Original disease in stage III.
  • ECOG performance status: 0-2.
  • Age: 20-80 years.
  • Previous chemotherapy with paclitaxel and carboplatin (only).
  • Previous cyto-reductive surgery.
  • Clinical Complete Response (both physically and by imaging).
  • CA 125 should be either normalized (in at least 50 patients) or while still in decreasing values at monthly measurements.
  • CBC at normal values or with any toxicity at a grade limited to I by NCIC-CTC.
  • Liver and renal functions \< 1.5 upper normal limits (UNL) by SMA.
  • The patient's signature on the informed consent.

You may not qualify if:

  • Mucinous type ovarian carcinoma.
  • Histological Grade I-II.
  • Current continuous treatment by steroids or by NSAIDs, or by anti-coagulants for "non protocol" reasons.
  • Previous history of active peptic ulcer.
  • Current participation in any other treatment study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma

Interventions

CyclophosphamideCelecoxibMethotrexate

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 DisordersNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsBenzenesulfonamidesSulfonamidesAmidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • David Loven, M.D.

    HaEmek Medical Center, Oncology Unit

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2010

First Posted

August 5, 2010

Study Start

August 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

IL(1)