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S9912 Combination Chemo in Stage III Ovarian Cancer,

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00003896
First received: November 1, 1999
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: cisplatin
Drug: liposomal doxorubicin
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter. ] [ Designated as safety issue: No ]
    From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.

  • Overall Survival [ Time Frame: Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter. ] [ Designated as safety issue: No ]
    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:
  • Adverse Events [ Time Frame: Weekly during 6 weeks of protocol treatment ] [ Designated as safety issue: Yes ]
    Only adverse events that are possibly, probably or definitely related to study drug are reported.


Enrollment: 68
Study Start Date: September 1999
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00003896

  Show 104 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Harriet O. Smith, MD University of New Mexico Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00003896     History of Changes
Other Study ID Numbers: CDR0000067066, S9912, U10CA032102
Study First Received: November 1, 1999
Results First Received: October 30, 2012
Last Updated: January 2, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 25, 2014