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

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00060359

Purpose

RATIONALE: Drugs used in chemotherapy such as polyglutamate paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Polyglutamate paclitaxel may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged. Combining polyglutamate paclitaxel with carboplatin may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of polyglutamate paclitaxel when given together with carboplatin in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer.

Condition	Intervention	Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	Drug: carboplatin Drug: paclitaxel poliglumex Procedure: adjuvant therapy	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin Paclitaxel Poliglumex

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose (MTD) as assessed by CTC version 2.0 during the first course of therapy [ Designated as safety issue: Yes ]
Feasibility as assessed by CTC version 2.0 weekly during treatment for up to 8 courses [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rates as measured by RECIST criteria after courses 4 and 8 [ Designated as safety issue: No ]
Pharmacokinetics as assessed by serum and urine measurements during courses 1-4 [ Designated as safety issue: No ]

Study Start Date:	April 2003
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

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.
Determine the feasibility of this regimen at the MTD in an expanded cohort of patients.
Determine the response rate and progression-free survival of patients treated with this regimen in the expanded cohort.
Determine the toxicity profile of this regimen in these patients.
Determine the pharmacokinetics and pharmacodynamics of this drug combination in these patients.

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.

PROJECTED ACCRUAL: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

GOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060359

Locations

United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242
United States, New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Camden, New Jersey, United States, 08103
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Oklahoma
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States, 74104
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Fox Chase-Temple Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Mark A. Morgan, MD, FACOG, FACS

Fox Chase Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Morgan MA, Darcy KM, Rose PG, Degeest K, Bookman MA, Aikins JK, Sill MW, Mannel RS, Allievi C, Egorin MJ. 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. 2008 Jun 30; [Epub ahead of print]

Study ID Numbers:	CDR0000301642, GOG-9914
Study First Received:	May 6, 2003
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00060359 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

ovarian clear cell cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian mixed epithelial carcinoma
ovarian mucinous cystadenocarcinoma
ovarian serous cystadenocarcinoma
ovarian undifferentiated adenocarcinoma

stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
Brenner tumor
fallopian tube cancer
peritoneal cavity cancer

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female

Endocrine System Diseases
Carboplatin
Antimitotic Agents
Abdominal Neoplasms
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009