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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


Phase 1
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) as assessed by CTC version 2.0 during the first course of therapy

Safety Issue:

Yes

Principal Investigator

Mark A. Morgan, MD, FACOG, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000301642

NCT ID:

NCT00060359

Start Date:

April 2003

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • 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
  • Carcinoma
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Fox Chase-Temple Cancer CenterPhiladelphia, Pennsylvania  19111-2442
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Cancer Institute of New Jersey at the Cooper University Hospital - VoorheesCamden, New Jersey  08103