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

Alternate Title

Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	GOG-9914 NCT00060359

Objectives

1. Determine the maximum tolerated dose (MTD) of polyglutamate paclitaxel in combination with carboplatin in patients with chemotherapy-naïve ovarian epithelial, primary peritoneal, or fallopian tube carcinoma.
2. Determine the feasibility of this regimen at the MTD in an expanded cohort of patients.
3. Determine the response rate and progression-free survival of patients treated with this regimen in the expanded cohort.
4. Determine the toxicity profile of this regimen in these patients.
5. Determine the pharmacokinetics and pharmacodynamics of this drug combination in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube carcinoma
  • Stage III or IV
  • Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery



• The following histologic epithelial cell types are eligible:
  • Serous adenocarcinoma
  • Mucinous adenocarcinoma
  • Clear cell adenocarcinoma
  • Transitional cell carcinoma
  • Adenocarcinoma not otherwise specified
  • Endometrioid adenocarcinoma
  • Undifferentiated carcinoma
  • Mixed epithelial carcinoma
  • Malignant Brenner tumor



• No epithelial tumors of low malignant potential (borderline tumors)



• Surgery performed within the past 12 weeks

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• More than 3 years since prior adjuvant chemotherapy for localized breast cancer (must be free of recurrent or metastatic disease)

Endocrine therapy

• Not specified

Radiotherapy

• More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin (must be free of recurrent or metastatic disease)
• No prior radiotherapy to any portion of the abdominal cavity or pelvis

Surgery

• See Disease Characteristics

Other

• No prior treatment, other than debulking surgery, for this cancer
• No prior treatment for another cancer that would contraindicate this protocol therapy
• No concurrent amifostine or other protective reagents

Patient Characteristics:

Age

• 18 and over

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• No active bleeding

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastasis)
• Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastasis)
• No acute hepatitis
• PT and PTT normal

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for the past 6 months
• No myocardial infarction within the past 6 months
• No unstable angina

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No neuropathy (sensory or motor) grade 2 or worse
• No other invasive malignancies within the past 5 years except nonmelanoma skin cancer or localized breast cancer
• No active infection requiring antibiotics
• No circumstances that would preclude study completion or follow-up

Expected Enrollment

A total of 3-64 patients (3-24 for dose-escalation phase and 20-40 for feasibility phase) will be accrued for this study within 4-10 months.

Outcomes

Maximum tolerated dose (MTD) as assessed by CTC version 2.0 during the first course of therapy
Feasibility as assessed by CTC version 2.0 weekly during treatment for up to 8 courses

Response rates as measured by RECIST criteria after courses 4 and 8
Pharmacokinetics as assessed by serum and urine measurements during courses 1-4

Outline

This is an open-label, multicenter, dose-escalation study of polyglutamate paclitaxel (CT-2103) followed by a feasibility, multicenter study.

• Dose-escalation phase: Patients receive CT-2103 IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

  Cohorts of 3-6 patients receive escalating doses of CT-2103 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of treatment.




• Feasibility phase: Once the MTD of CT-2103 is determined, an additional 20-40 patients receive treatment at that dose level combined with carboplatin as above.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Morgan MA, Darcy KM, Rose PG, et al.: Paclitaxel poliglumex and carboplatin as first-line therapy in ovarian, peritoneal or fallopian tube cancer: a phase I and feasibility trial of the Gynecologic Oncology Group. Gynecol Oncol 110 (3): 329-35, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Mark Morgan, MD, FACOG, FACS, Protocol chair		Ph: 215-214-1430; 888-369-2427 Email: mark.morgan@fccc.edu

Registry Information
Official Title		An Expanded Cohort Phase I Study Of CT-2103 (IND #61013) And Carboplatin In Patients With Previously Untreated Epithelial Ovarian Carcinoma Or Primary Peritoneal Carcinoma
Trial Start Date		2003-04-07
Trial Completion Date		2009-01-25
Registered in ClinicalTrials.gov		NCT00060359
Date Submitted to PDQ		2003-03-31
Information Last Verified		2005-12-14
NCI Grant/Contract Number		U10-CA27469

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