Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer
This study has been completed.
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00060359
First received: May 6, 2003
Last updated: April 23, 2011
Last verified: December 2005
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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 Primary Peritoneal Cavity Cancer |
Drug: carboplatin Drug: paclitaxel poliglumex Procedure: adjuvant therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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:
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) |
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 | |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| 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 | |
| Lake/University Ireland Cancer Center | |
| Mentor, Ohio, United States, 44060 | |
| United States, Oklahoma | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Cancer Care Associates - Midtown Tulsa | |
| Tulsa, Oklahoma, United States, 74104 | |
| 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
Investigators
| Study Chair: | Mark A. Morgan, MD, FACOG, FACS | Fox Chase Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00060359 History of Changes |
| Other Study ID Numbers: | CDR0000301642, GOG-9914 |
| Study First Received: | May 6, 2003 |
| Last Updated: | April 23, 2011 |
| 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 primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Carcinoma Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013