Denileukin Diftitox in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer - Full Text View

Sponsored by:	University of Texas
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00238186

Purpose

RATIONALE: Biological therapies, such as denileukin diftitox, may be able to carry tumor-killing substances directly to tumor cells.

PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with stage III or stage IV ovarian epithelial or primary peritoneal cancer.

Condition	Intervention	Phase
Ovarian Cancer Peritoneal Cavity Cancer	Biological: denileukin diftitox	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	A Phase II Trial of Intravenous Ontak to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, Failing or Ineligible for First-Line Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Denileukin diftitox

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Clinical response rate [ Designated as safety issue: No ]
Disease-free progression [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Immunological studies [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Tolerability [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	December 2005
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the efficacy of denileukin diftitox, in terms of clinical response rate, disease-free progression, and overall survival, in patients with stage III or IV ovarian epithelial or primary peritoneal cancer.

Secondary

Determine the immune-modulating effects of this drug in these patients.
Determine the toxicity of this drug in these patients.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive denileukin diftitox IV over 1 hour once in week 1. Courses repeat monthly in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond achieving a documented response.

After completion of study treatment, patients are followed at 6 weeks, 3 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 20-60 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed* ovarian epithelial or primary peritoneal cancer
- Stage III or IV disease
- Failed OR ineligible for OR intolerant of prior first-line therapy NOTE: *Clinically recurrent disease without histologic confirmation allowed
Measurable disease
Brain metastases allowed
No germ cell or stromal cell ovarian cancer

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 6 months

Hematopoietic

Hemoglobin ≥ 8.5 g/dL
Absolute neutrophil count ≥ 750/mm^3
Platelet count ≥ 40,000/mm^3

Hepatic

Albumin ≥ 2.5 g/dL
SGOT < 5 times upper limit of normal

Renal

Creatinine < 2.0 mg/dL

Cardiovascular

No symptomatic coronary artery disease (e.g., uncontrolled angina or congestive heart failure)
No uncontrolled hypertension (i.e., diastolic blood pressure > 100 mm Hg or systolic blood pressure > 160 mm Hg on a regular basis)
No uncontrolled, symptomatic cardiac arrhythmia

Immunologic

No history of autoimmune disease, including any of the following conditions:
- Systemic lupus erythematosus
- Psoriasis
- Inflammatory bowel disease
No untreated or uncontrolled infection

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to tolerate phlebotomy
No contraindication to study treatment
No other active major medical problem
No other uncured malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent immune-modulating drugs except as premedication for denileukin diftitox
No anticancer immune-modulating drugs for 1 month after completion of study treatment

Chemotherapy

More than 2 weeks since prior and no concurrent chemotherapy
No anticancer chemotherapy for 1 month after completion of study treatment

Endocrine therapy

No concurrent anticancer steroids
No anticancer steroids during and for 1 month after completion of study treatment

Radiotherapy

More than 1 month since prior and no concurrent radiotherapy
No anticancer radiotherapy for 1 month after completion of study treatment

Surgery

No concurrent surgery

Other

No other concurrent anticancer therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238186

Locations

United States, Texas
University of Texas Health Science Center at San Antonio	Recruiting
San Antonio, Texas, United States, 78229-3900
Contact: Tyler Curiel, MD, MPH 210-567-4777 curielt@uthscsa.edu

Sponsors and Collaborators

University of Texas

Investigators

Study Chair:	Tyler Curiel, MD, MPH	University of Texas
Investigator:	Pui C. Cheng, MD	Tulane University Health Sciences Center
Investigator:	Danny R. Barnhill, MD	Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Texas Health Science Center at San Antonio ( Tyler Curiel )
Study ID Numbers:	CDR0000445063, UTHSC-HSC20070042H, TULCC-TC-01-4, TULCC-C0307
Study First Received:	October 12, 2005
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00238186 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer

Study placed in the following topic categories:

Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian Epithelial Cancer
Abdominal Neoplasms
Recurrence
Carcinoma
Genital Diseases, Female

Digestive System Diseases
Analgesics, Non-Narcotic
Interleukin-2
Denileukin diftitox
Peritoneal Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Peripheral Nervous System Agents
Analgesics
Endocrinopathy
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Peritoneal Diseases
Analgesics
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms

Genital Neoplasms, Female
Endocrine System Diseases
Abdominal Neoplasms
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Digestive System Diseases
Interleukin-2
Analgesics, Non-Narcotic
Denileukin diftitox
Peritoneal Neoplasms
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009