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

NCT00102622 | Terminated Phase 1 DMC

• 2 other identifiers: ID02-321P50CA083639
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer

Keywords

Ovary; ovarian cancer; biologic therapy; platinum-resistant; platinum-refractory ovarian cancer; platinum-resistant ovarian cancer; paclitaxel; tgDCC-E1A; E1A; Taxol

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Intraperitoneal (IP) tgDCC-E1A in combination with Intravenous (IV) Paclitaxel

  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.

  6 week cycle (cycle consists of 6 weekly treatments)

Secondary Outcomes (1)

• Tumor response of intraperitoneal (IP) tgDCC-E1A in combination with intravenous (IV) paclitaxel compared to IV paclitaxel alone

  5 Years

Study Arms (2)

Arm 1: Paclitaxel + tgDCC-E1A

EXPERIMENTAL

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; Drug: Paclitaxel

Arm 2: Paclitaxel Alone

ACTIVE COMPARATOR

Weekly single agent intravenous Paclitaxel 80 mg/m\^2 for six treatments every 7 days.

Drug: Paclitaxel

Interventions

Intraperitoneal tgDCC-E1A BIOLOGICAL

Starting Dose Level: 1.8 mg DNA/m\^2 intraperitoneal every 7 days +/- 2 days for a total of 6 treatments each cycle.

Also known as: E1A

Arm 1: Paclitaxel + tgDCC-E1A

Paclitaxel DRUG

80 mg/m\^2 intravenous (IV) every 7 days +/- 2 days for a total of 6 treatments.

Also known as: Taxol

Arm 1: Paclitaxel + tgDCC-E1A; Arm 2: Paclitaxel Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas MD Anderson Cancer Center official website

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Naoto Ueno, MD, PHD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2005
• First Posted: February 1, 2005
• Study Start: December 1, 2004
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 13, 2018

Record last verified: 2018-11

Locations

US (1)