Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Carboplatin With or Without Liposomal Doxorubicin in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Not specified NCI SWOG-S0200 S0200, NCT00043082

Special Category: CTSU trial

Objectives

1. Compare overall survival of patients with platinum-sensitive recurrent ovarian epithelial or primary peritoneal cancer treated with carboplatin with or without pegylated doxorubicin HCl liposome.
2. Compare progression-free survival, confirmed complete response rates, and time to treatment failure in patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed ovarian epithelial carcinoma
  • Stage III or IV disease at time of initial staging laparotomy



• Primary peritoneal and mixed Mullerian tumors allowed



• No borderline ovarian tumors



• Disease progression or recurrence after a progression-free and platinum-free interval of 6-24 months after completion of first-line platinum-based chemotherapy (either single agent or combination therapy)



• Disease progression or recurrence based solely on CA 125 elevation allowed, provided that one of the following is true:
  • Prior baseline CA 125 greater than 35 U/mL and subsequent normalization of no greater than 35 U/mL must have CA 125 greater than 2 times upper limit of normal (ULN) on 2 occasions at least 1 week apart
  • Prior baseline CA 125 greater than 35 U/mL that never normalized must have CA 125 greater than 2 times the nadir value on 2 occasions at least 1 week apart
  • Prior normal baseline CA 125 (no greater than 35 U/mL) must show CA 125 greater than 2 times ULN on 2 occasions at least 1 week apart



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• At least 28 days since prior biologic consolidation therapy
• No concurrent immunotherapy

Chemotherapy

• See Disease Characteristics
• At least 28 days since prior non-platinum-containing consolidation chemotherapy
• No prior pegylated doxorubicin HCl liposome
• No prior cumulative anthracycline (e.g., doxorubicin, daunorubicin, epirubicin) dose in excess of 240 mg/m²
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent hormonal therapy

Radiotherapy

• No prior abdominopelvic irradiation
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• At least 28 days since prior surgical debulking for disease progression or recurrence and recovered
• No concurrent surgery

Other

• No other prior treatment during the 6-24 month progression-free and platinum-free interval except up to 12 courses of consolidation therapy
• No other concurrent anticancer therapy

Patient Characteristics:

Age

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 10 g/dL

Hepatic

• SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2 times ULN
• Bilirubin no greater than ULN

Renal

• Creatinine no greater than 1.9 mg/dL

Cardiovascular

• No New York Heart Association class II-IV cardiac disease
• No clinical evidence of congestive heart failure
• Ejection fraction greater than 50% by MUGA or 2-dimensional echocardiogram

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or incidental carcinoid cancer
• No evidence of active or uncontrolled infection
• No severe gastrointestinal symptoms (i.e., partial obstruction) and/or gastrointestinal bleeding or diarrhea
• No greater than grade 1 preexisting sensory neuropathy

Expected Enrollment

A total of 900 patients will be accrued for this study within 4 years.

Outline

This is a randomized, multicenter study. Patients are stratified according to disease measurability (elevated CA 125 only vs nonmeasurable disease only with or without elevated CA 125 vs measurable disease), number of disease sites (2 or fewer vs 3 or more), and serous tumor histology (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive carboplatin IV over 15 minutes and pegylated doxorubicin HCl liposome IV over 1 hour on day 1.



• Arm II: Patients receive carboplatin IV as in arm I.

Treatment in both arms repeats every 4 weeks for a total of 15 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, every 6 months for 3 years, and then annually for 7 years.

Alberts DS, Liu PY, Wilczynski SP, et al.: Randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy (Southwest Oncology Group Protocol S0200). Gynecol Oncol 108 (1): 90-4, 2008.[PUBMED Abstract]

Alberts DS, Liu PY, Wilczynski S, et al.: Phase III randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy: Southwest Oncology Group protocol S0200. [Abstract] J Clin Oncol 25 (Suppl 18): A-5551, 286s, 2007.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

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

Registry Information
Official Title		A Phase III Randomized Study of Liposomal Doxorubicin Plus Carboplatin Versus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian and Peritoneal Carcinoma After Failure of Initial Platinum-Based Chemotherapy
Trial Start Date		2002-08-15
Registered in ClinicalTrials.gov		NCT00043082
Date Submitted to PDQ		2002-06-21
Information Last Verified		2004-08-26
NCI Grant/Contract Number		CA32102

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