Intraperitoneal tgDCC-E1 and Intravenous Paclitaxel in Women With Platinum-Resistant Ovarian Cancer

This study has been terminated.
(Phase I/II study that did not progress to Phase II due to low accrual.)
Sponsor:
Collaborators:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00102622
First received: January 31, 2005
Last updated: June 4, 2014
Last verified: August 2012
  Purpose

The goal of this clinical research study is to find the highest safe dose of intraperitoneal tgDCC-E1A that can be given in combination with paclitaxel as a treatment for patients with recurrent, platinum-resistant ovarian cancer. How the cancer responds to this treatment will also be studied. Researchers will also ask the patients if they will allow additional tumor samples to be collected and extra blood samples to be drawn. These samples will be used to learn about the biological response before and after treatment.


Condition Intervention Phase
Ovarian Cancer
Biological: Intraperitoneal tgDCC-E1A
Drug: Paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I of Phase I/II Randomized Study of Intraperitoneal tgDCC-E1 and Intravenous Paclitaxel in Women With Platinum-Resistant Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Intraperitoneal (IP) tgDCC-E1A in combination with Intravenous (IV) Paclitaxel [ Time Frame: 6 week cycle (cycle consists of 6 weekly treatments) ] [ Designated as safety issue: Yes ]
    Dose combinations assigned using the Continuous Reassessment Method (CRM) with up to 8 cohorts of three subjects each assigned to one of the three tgDCC-E1A dose combinations (1.8 , 3.6 or 5.0 mg DNA/m^2). Three weeks after third subject started treatment, the number of subjects who experienced dose limiting toxicities (DLT) tabulated. The next cohort of three subjects assigned to same or next higher dose combination using a computer algorithm that evaluates proportion of subjects who experienced a DLT.


Secondary Outcome Measures:
  • Tumor response of intraperitoneal (IP) tgDCC-E1A in combination with intravenous (IV) paclitaxel compared to IV paclitaxel alone [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response: disappearance all target & non-target lesions, no evidence new lesions in 2 disease assessments 4 weeks apart; Partial Response (PR): >30% decrease in sum longest dimensions (LD) of all target measurable lesions reference baseline sum of LD; 2 disease assessments 4 weeks apart required. IF ONLY target lesion is solitary pelvic mass measured by physical exam, not radiographically measurable, 50% decrease in LD required; Progressive disease (PD): >20% increase in sum LD of target lesions references smallest sum LD or appearance new lesions. IF ONLY target lesion is solitary pelvic mass measured by physical exam, not radiographically measurable, 50% increase in LD required; Stable disease: neither sufficient shrinkage for PR nor increase for PD, reference smallest sum LD since treatment started, or IF non-target lesions persistence of 1+ non-target lesions and/or maintenance of tumor marker above normal limits.


Enrollment: 18
Study Start Date: December 2004
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Paclitaxel + tgDCC-E1A
80 mg/m^2 intravenous Paclitaxel and intraperitoneal (IP) tgDCC-E1A starting dose 1.8 mg DNA/m^2 weekly for six treatments every 7 days.
Biological: Intraperitoneal tgDCC-E1A
Starting Dose Level: 1.8 mg DNA/m^2 intraperitoneal every 7 days +/- 2 days for a total of 6 treatments each cycle.
Other Name: E1A
Drug: Paclitaxel
80 mg/m^2 intravenous (IV) every 7 days +/- 2 days for a total of 6 treatments.
Other Name: Taxol
Active Comparator: Arm 2: Paclitaxel Alone
Weekly single agent intravenous Paclitaxel 80 mg/m^2 for six treatments every 7 days.
Drug: Paclitaxel
80 mg/m^2 intravenous (IV) every 7 days +/- 2 days for a total of 6 treatments.
Other Name: Taxol

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Recurrent epithelial ovarian cancer or primary peritoneal cancer with histologic confirmation of the original tumor. Recurrent disease may be manifested as an elevated cancer antigen (CA)-125 using the following criteria: (a) increase in CA-125 to at least 2 times the upper limit of normal (assayed on 2 occasions at least 7 days apart) for subjects with a history of normal pre-treatment values or values that normalized with the most recent treatment - OR - (b) increase in CA-125 to 2 times the lowest observed value on the most recent treatment (assayed on two occasions at least 7 days apart) for subjects whose CA-125 did not normalize with the most recent treatment.
  • Platinum-resistant disease, defined as recurrence less than six months after discontinuation of treatment with platinum therapy or platinum-refractory disease defined as progression on a platinum-containing regimen.
  • A treatment-free interval of at least three weeks for cytotoxic therapies, radiation therapy, or other experimental drugs prior to first treatment on this protocol.
  • A Zubrod performance status of two or less.

Exclusion Criteria:

  • Previous administration of tgDCC-E1A.
  • Progression on any taxane-containing regimen, or recurrent within 6 months of receiving a weekly taxane-containing regimen.

Previous radiation to more than 25% of marrow-bearing areas.

  • Any of the following laboratory values: Hemoglobin <9.0 gm/dl, absolute neutrophil count (ANC) <1.5 K/ml, platelet <100 K/ml, creatinine >2 mg/dl, bilirubin >2 mg/dl, Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)>2 times the upper limit of normal, or abnormal coagulation profiles (>2 seconds beyond upper range of normal Prothrombin Time (PT) or Partial thromboplastin time (PTT)).
  • Known human immunodeficiency virus (HIV)-positive status or active systemic infection.
  • History of other invasive malignancies, except for non-melanoma skin cancer, unless there is no evidence of other cancer within the past 5 years.
  • Patients with grade 2 or greater neurotoxicity.
  • Patients with unstable angina or those who have had a myocardial infarction within the past six months. Patients with evidence of abnormal cardiac conduction are eligible if their disease has been stable for the past six months. Patients with an ejection fraction under 40%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102622

Locations
United States, Texas
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Naoto Ueno, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00102622     History of Changes
Other Study ID Numbers: ID02-321, P50CA083639
Study First Received: January 31, 2005
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Ovary
ovarian cancer
biologic therapy
platinum-resistant
platinum-refractory ovarian cancer
platinum-resistant ovarian cancer
paclitaxel
tgDCC-E1A
E1A
Taxol

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014