Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Objectives

I.  Compare in a randomized Phase III setting the therapeutic efficacy of and 
toxicities associated with intermediate-dose intraperitoneal vs. intravenous 
cis-platinum when combined with intravenous cyclophosphamide in patients with 
optimal Stage III ovarian carcinoma.
II.  Determine whether the human tumor clonogenic assay with a wide range of 
drug concentration testing can accurately predict pathologic complete response 
to 2-drug combination chemotherapy in the setting of systemic and 
intraperitoneal drug administration.

Entry Criteria

Disease Characteristics:

Histologically confirmed ovarian carcinoma of epithelial
origin, i.e.:

  Serous cystadenocarcinoma
  Undifferentiated adenocarcinoma
  Endometrioid adenocarcinoma
  Mucinous cystadenocarcinoma
  Mesonephroid adenocarcinoma
  Mixed epithelial carcinoma

  No mixed germinal or stromal cell types

  No borderline or "probably malignant" tumors

Pathologically confirmed surgically optimal Stage III disease
required, i.e.:

  No residual disease at the time of surgery OR

  Residual disease with no lesions greater than 2 cm in
  largest diameter in abdomen or pelvis

  Registration allowed with only clinical confirmation of
  surgically optimal Stage III disease (final validation of
  eligibility requires pathologic confirmation)

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior pelvic irradiation

Surgery:
  Bilateral salpingo-oophorectomy and total abdominal
  hysterectomy with omentectomy required within 4 weeks prior
  to entry

Patient Characteristics:

Age:
  18 and over

Performance status:
  SWOG 0-2

Hematopoietic:
  WBC at least 3,500
  Platelets at least 100,000

Hepatic:
  Not specified

Renal:
  Creatinine no more than 1.5 mg/dl
  Creatinine clearance at least 40 ml/min

Other:
  No septicemia or severe infection
  No severe gastrointestinal symptoms (i.e., partial
     obstruction)
  No bleeding
  No prior or concurrent malignancy except:
     Nonmelanomatous skin cancer
     Cervical carcinoma in situ

Blood/body fluid analyses to determine eligibility and
imaging studies and physical exams for tumor measurement
completed within 14 days prior to registration; screening
exams other than blood/body fluid analyses and imaging
studies of nonmeasurable disease or uninvolved organs
completed within 42 days prior to registration

Expected Enrollment

About 450 patients will be randomized during the 3.5-year accrual period.

Outline

Randomized study.
Arm I:  2-Drug Combination Chemotherapy.  Intravenous cis-Platinum, CACP, 
NSC-119875; Intravenous Cyclophosphamide, CTX, NSC-26271.
Arm II:  2-Drug Combination Chemotherapy.  Intraperitoneal CACP; Intravenous 
CTX.

Alberts DS, Liu PY, Hannigan EV, et al.: Phase III study of IP cisplatin plus IV cyclophosphamide vs IV cisplatin plus IV cyclphosphamide in optimal disease stage III ovarian cancer: an Intergroup study 0051 (SWOG-GOG-ECOG). [Abstract] Society of Gynecologic Oncologists Abstract Book 1: 40, 1996.

Alberts DS, Liu PY, Hannigan EV, et al.: Intraperitoneal cisplatin plus intravenous cyclophosphamide versus intravenous cisplatin plus intravenous cyclophosphamide for stage III ovarian cancer. N Engl J Med 335 (26): 1950-5, 1996.[PUBMED Abstract]

Alberts DS, Liu PY, Hannigan EV, et al.: Phase III study of intraperitoneal (ip) cisplatin (CDDP)/intravenous (iv) cyclophosphamide (CPA) vs iv CDDP/iv CPA in patients (pts) with optimal disease stage III ovarian cancer: a SWOG-GOG-ECOG intergroup study (INT 0051). [Abstract] Proceedings of the American Society of Clinical Oncology 14: A760, 273, 1995.

Alberts DS, Delforge A: Maximizing the delivery of intraperitoneal therapy while minimizing drug toxicity and maintaining quality of life. Semin Oncol 33 (6 Suppl 12): S8-17, 2006.[PUBMED Abstract]

Markman M: Clinical efficacy supporting the role of intraperitoneal drug delivery in the primary chemotherapeutic management of small-volume residual advanced ovarian cancer. Semin Oncol 33 (6 Suppl 12): S3-7, 2006.[PUBMED Abstract]

Singhal P, Lele S: Intraperitoneal chemotherapy for ovarian cancer: where are we now? J Natl Compr Canc Netw 4 (9): 941-6, 2006.[PUBMED Abstract]

Heddens D, Alberts DS, Hannigan EV, et al.: Prediction of the need for red cell transfusion in newly diagnosed ovarian cancer patients undergoing platinum-based treatment. Gynecol Oncol 86 (3): 239-43, 2002.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

David Alberts, MD, Protocol chair		Ph: 520-626-7685; 800-622-2673

Gynecologic Oncology Group

Stephen Williams, MD, Protocol chair		Ph: 317-278-0070; 888-600-4822 Email: stdwilli@IUPUI.edu

Eastern Cooperative Oncology Group

James Young, MD, Protocol chair		Ph: 719-776-5454

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