Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003385

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, paclitaxel, and carboplatin in treating patients who have untreated ovarian, peritoneal, or fallopian tube cancer.

Condition	Intervention	Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer	Drug: carboplatin Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Paclitaxel Carboplatin

U.S. FDA Resources

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

Estimated Enrollment:	48
Study Start Date:	March 1999
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with paclitaxel and carboplatin in patients with previously untreated ovarian epithelial, peritoneal, or fallopian tube cancer.
Determine the toxicity of this treatment regimen in these patients.
Evaluate measurable disease in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of doxorubicin HCl liposome (LipoDox).

Patients receive LipoDox IV on day 1, carboplatin IV over 3 hours on days 1 and 22, and paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 4 courses in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of LipoDox until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 12 patients receives LipoDox at the MTD with carboplatin and paclitaxel as above.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study within 2 years.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed previously untreated ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma
The following histologic epithelial cell types are eligible:
- Serous adenocarcinoma
- Endometrioid adenocarcinoma
- Mucinous adenocarcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Mixed epithelial carcinoma
- Transitional cell
- Malignant Brenner tumor
- Adenocarcinoma not otherwise specified
No more than 12 weeks since diagnosis
No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

GOG 0-2

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm^3
Platelet count at least 100,000/mm^3
Absolute granulocyte count at least 1,500/mm^3

Hepatic:

Bilirubin no greater than 1.5 times normal
SGOT/SGPT no greater than 3 times normal
Alkaline phosphatase no greater than 3 times normal
Gamma-glutamyl-transferase no greater than 3 times normal
No acute hepatitis

Renal:

Creatinine no greater than 2.0 mg/dL OR
Creatinine clearance greater than 50 mL/min

Cardiovascular:

LVEF normal by MUGA
No unstable angina
No myocardial infarction within the past 6 months
Patients with abnormal cardiac conduction (e.g., bundle branch block or heart block) are eligible if disease has been stable for the past 6 months

Other:

No septicemia or severe infection
No severe gastrointestinal bleeding
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy

Surgery:

Recovered from recent prior surgery

Other:

No prior anticancer therapy that would preclude study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003385

Locations

United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Peter G. Rose, MD

MetroHealth Cancer Care Center at MetroHealth Medical Center

More Information

Additional Information:

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

Publications:

Rose PG, Greer BE, Horowitz IR, Markman M, Fusco N. Paclitaxel, carboplatin and pegylated liposomal doxorubicin in ovarian and peritoneal carcinoma: a phase I study of the Gynecologic Oncology Group. Gynecol Oncol. 2007 Jan;104(1):114-9. Epub 2006 Sep 7.

Rose PG, Greer BE, Markman M, et al.: A phase I study of paclitaxel, carboplatin, and liposomal doxorubicin in ovarian, peritoneal, and tubal carcinoma: a Gynecologic Oncology Group Study. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A-1531, 2000.

ClinicalTrials.gov Identifier:	NCT00003385 History of Changes
Other Study ID Numbers:	CDR0000066381, GOG-9703
Study First Received:	November 1, 1999
Last Updated:	April 23, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
ovarian undifferentiated adenocarcinoma
ovarian mixed epithelial carcinoma
ovarian serous cystadenocarcinoma

ovarian mucinous cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian clear cell cystadenocarcinoma
fallopian tube cancer
primary peritoneal cavity cancer
Brenner tumor

Additional relevant MeSH terms:

Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube 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
Abdominal Neoplasms
Digestive System Neoplasms

Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Doxorubicin
Carboplatin
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 12, 2012