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A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal Carcinoma

Phase 1
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Phase I Study of Paclitaxel, Carboplatin, and Increasing Doses of Doxil in Untreated Ovarian, Peritoneal, and Tubal Carcinoma


- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter G. Rose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

MetroHealth Cancer Care Center at MetroHealth Medical Center


United States: Federal Government

Study ID:




Start Date:

March 1999

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • 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
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
MBCCOP - Hawaii Honolulu, Hawaii  96813
Ireland Cancer Center Cleveland, Ohio  44106-5065
University of Texas Medical Branch Galveston, Texas  77555-1329
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182