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A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer

NCT01616303 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2020-09-14

No results posted yet for this study

Summary

This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy (carboplatin and paclitaxel alone) in female patients with advanced ovarian cancer.

Conditions

  • Ovarian Neoplasms

Interventions

DRUG

Carboplatin

carboplatin (area under the curve (AUC) 6, administered intravenously in a single day for 6 cycles every three weeks \[21 days\])

DRUG

Paclitaxel

Paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks \[21 days\])

BIOLOGICAL

oregovomab

oregovomab (2 mg infused intravenously jointly during the 1st, 3rd and 5th chemotherapy cycle and 12 weeks after the 5th cycle).

Sponsors & Collaborators

  • Quest PharmaTech Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Woo, M.Sc. · Quest PharmaTech Inc.

  • Christopher Nicodemus, MD FACP · AIT Strategies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-15
Primary Completion
2015-06-15
Completion
2018-10-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01616303 on ClinicalTrials.gov