Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group Identifier:
First received: November 1, 1999
Last updated: May 24, 2013
Last verified: September 2003

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 1

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:

Further study details as provided by Gynecologic Oncology Group:

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


  • 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.


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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)



  • Not specified

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified


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


  • 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


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


  • 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


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


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • No prior radiotherapy


  • Recovered from recent prior surgery


  • No prior anticancer therapy that would preclude study
  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 identifier: NCT00003385

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
Norwegian Radium Hospital
Oslo, Norway, N-0310
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Peter G. Rose, MD MetroHealth Cancer Care Center at MetroHealth Medical Center
  More Information

Additional Information:
Publications: Identifier: NCT00003385     History of Changes
Other Study ID Numbers: CDR0000066381, GOG-9703
Study First Received: November 1, 1999
Last Updated: May 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
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:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Peritoneal Diseases
Urogenital Neoplasms
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on October 09, 2015