Full Text View
Tabular View
No Study Results Posted
Related Studies
Combination Chemotherapy in Treating Women With Stage III Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
This study has been completed.
Study NCT00003896   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: June 10, 2009   History of Changes

November 1, 1999
June 10, 2009
September 1999
January 2009   (final data collection date for primary outcome measure)
Progression-free survival [ Designated as safety issue: No ]
Progression-free survival
Complete list of historical versions of study NCT00003896 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy in Treating Women With Stage III Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer

RATIONALE: Drugs used in chemotherapy work in 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 II trial to study the effectiveness of combining paclitaxel, cisplatin, and liposomal doxorubicin in treating women who have undergone surgery for stage III ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

OBJECTIVES:

  • Determine the efficacy of intraperitoneal (IP) cisplatin, IP and IV paclitaxel, and IV doxorubicin HCl liposome, in terms of progression-free survival and overall survival, in patients with optimally debulked stage III ovarian epithelial, fallopian tube, or primary peritoneal cancer.
  • Determine the feasibility of and toxic effects associated with this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours on day 1, intraperitoneal (IP) cisplatin over 30-60 minutes on day 2, IP paclitaxel over 30-60 minutes on day 8, and doxorubicin HCl liposome IV over 1 hour on day 8. Patients not able to tolerate IP infusion receive paclitaxel IV and cisplatin IV on day 1 only. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 4 years.

Phase II
Interventional
Treatment, Open Label
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • Drug: cisplatin
  • Drug: paclitaxel
  • Drug: pegylated liposomal doxorubicin hydrochloride
  • Procedure: adjuvant therapy
 
Smith HO, Moon J, Wilczynski SP, Tiersten AD, Hannigan EV, Robinson WR, Rivkin SE, Anderson GL, Liu PY, Markman M. Southwest Oncology Group Trial S9912: Intraperitoneal cisplatin and paclitaxel plus intravenous paclitaxel and pegylated liposomal doxorubicin as primary chemotherapy of small-volume residual stage III ovarian cancer. Gynecol Oncol. 2009 May 21; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
62
 
January 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III ovarian epithelial, fallopian tube, or primary peritoneal carcinoma

    • Tumor involves one or both ovaries with microscopically confirmed peritoneal metastasis outside the pelvis and/or regional lymph node metastasis
    • No tumors of borderline or low malignant potential only
    • Mixed Mullerian tumors allowed
  • Must have optimal disease defined as no residual lesions after resection or residual disease such that no single lesion measures greater than 1 cm in diameter
  • Must have undergone staging exploratory laparotomy with tumor debulking within the past 70 days

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • SWOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic:

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • SGOT or SGPT ≤ 2 times ULN

Renal:

  • Creatinine clearance ≥ 50 mL/min

Cardiovascular:

  • No congestive heart failure
  • No cardiac arrhythmia
  • No myocardial infarction or unstable angina within the past 6 months
  • Patients with a history of myocardial disease must not have ischemia or pathologic arrhythmias and must have an ejection fraction > 50% by MUGA

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active or uncontrolled infection
  • No concurrent fever
  • No grade 2 or greater sensory neuropathy
  • No severe gastrointestinal symptoms (i.e., partial obstruction) and/or bleeding, diarrhea, or abdominal tenderness suggestive of peritoneal irritation or infection
  • No erythema or tenderness of abdominal incision or port site suggestive of underlying infection
  • No other malignancy within the past five years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy for ovarian cancer

Chemotherapy:

  • No prior chemotherapy for ovarian cancer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior pelvic radiotherapy for ovarian cancer

Surgery:

  • See Disease Characteristics
  • Recovered from all reversible surgery-related toxic effects

Other:

  • No other concurrent antitumor treatment
  • No concurrent antibiotics for infection of undetermined etiology
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003896
 
CDR0000067066, SWOG-S9912
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Harriet O. Smith, MD University of New Mexico
National Cancer Institute (NCI)
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP