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Combination Chemotherapy in Treating Women With Stage III Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: June 10, 2009   History of Changes
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003896
  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: paclitaxel
Drug: pegylated liposomal doxorubicin hydrochloride
Procedure: adjuvant therapy
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: September 1999
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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
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
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067066, SWOG-S9912
Study First Received: November 1, 1999
Last Updated: June 10, 2009
ClinicalTrials.gov Identifier: NCT00003896     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
peritoneal cavity cancer
fallopian tube cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Anti-Bacterial Agents
Cisplatin
Peritoneal Diseases
Ovarian Cancer
Endocrine Gland Neoplasms
Digestive System Neoplasms
Ovarian Neoplasms
Genital Neoplasms, Female
Adjuvants, Immunologic
Endocrine System Diseases
Antimitotic Agents
Abdominal Neoplasms
Ovarian Epithelial Cancer
Fallopian Tube Neoplasms
Doxorubicin
Fallopian Tube Diseases
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Gastrointestinal Neoplasms
Peritoneal Neoplasms
Endocrinopathy
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Antibiotics, Antineoplastic
Genital Diseases, Female
Neoplasms by Site
Cisplatin
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Antimitotic Agents
Abdominal Neoplasms
Fallopian Tube Neoplasms
Doxorubicin
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators

ClinicalTrials.gov processed this record on July 02, 2009