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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003385
Other study ID # CDR0000066381
Secondary ID GOG-9703
Status Completed
Phase Phase 1
First received November 1, 1999
Last updated May 24, 2013
Start date March 1999

Study information

Verified date September 2003
Source Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Primary Purpose: Treatment


Intervention

Drug:
carboplatin

paclitaxel

pegylated liposomal doxorubicin hydrochloride


Locations

Country Name City State
Norway Norwegian Radium Hospital Oslo
United States Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda Maryland
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Ireland Cancer Center Cleveland Ohio
United States University of Texas Medical Branch Galveston Texas
United States MBCCOP - Hawaii Honolulu Hawaii
United States Holden Comprehensive Cancer Center Iowa City Iowa
United States Fred Hutchinson Cancer Research Center Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Norway, 

References & Publications (2)

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. — View Citation

Rose PG, Rodriguez M, Waggoner S, Greer BE, Horowitz IR, Fowler JM, McGuire WP. Phase I study of paclitaxel, carboplatin, and increasing days of prolonged oral etoposide in ovarian, peritoneal, and tubal carcinoma: a gynecologic oncology group study. J Cl — View Citation

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