S9912 Combination Chemo in Stage III Ovarian Cancer,

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003896
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : November 29, 2012
Last Update Posted : January 4, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Drug: cisplatin Drug: liposomal doxorubicin Drug: paclitaxel Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Intravenous Paclitaxel, Intraperitoneal Cisplatin, Intravenous Liposomal Doxorubicin and Intraperitoneal Paclitaxel in Women With Optimally-Debulked Stage III Epithelial Ovarian Cancer
Study Start Date : September 1999
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Experimental: Paclitaxel/cisplatin/Liposomal Doxorubicin
paclitaxel, cisplatin and liposomal doxorubicin
Drug: cisplatin
Other Name: platinol
Drug: liposomal doxorubicin
Other Names:
  • pegylated liposomal doxorubicin hydrochloride
  • doxil
Drug: paclitaxel
Other Name: taxol

Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter. ]
    From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.

  2. Overall Survival [ Time Frame: Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter. ]
    from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Weekly during 6 weeks of protocol treatment ]
    Only adverse events that are possibly, probably or definitely related to study drug are reported.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Performance status:

  • SWOG 0-1

Life expectancy:

  • Not specified


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


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


  • Creatinine clearance ≥ 50 mL/min


  • 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


  • 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


Biologic therapy:

  • No prior immunotherapy for ovarian cancer


  • No prior chemotherapy for ovarian cancer

Endocrine therapy:

  • Not specified


  • No prior pelvic radiotherapy for ovarian cancer


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


  • No other concurrent antitumor treatment
  • No concurrent antibiotics for infection of undetermined etiology

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003896

  Show 104 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Harriet O. Smith, MD University of New Mexico Cancer Center

Publications of Results:
Responsible Party: Southwest Oncology Group Identifier: NCT00003896     History of Changes
Other Study ID Numbers: CDR0000067066
S9912 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: November 29, 2012
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by Southwest Oncology Group:
stage III ovarian epithelial cancer
peritoneal cavity cancer
fallopian tube cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic