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PHASE I STUDY OF INTERFERON ENHANCED INTRAPERITONEAL RADIOIMMUNO-CHEMOTHERAPY FOR OVARIAN CANCER


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

Thank you

Trial Information

PHASE I STUDY OF INTERFERON ENHANCED INTRAPERITONEAL RADIOIMMUNO-CHEMOTHERAPY FOR OVARIAN CANCER


OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) of intraperitoneal paclitaxel and topotecan
when administered as a radiosensitizer prior to intraperitoneal lutetium Lu 177 monoclonal
antibody CC49 (177Lu-CC49) following subcutaneous interferon alfa-2b (IFN-A) in patients
with persistent or recurrent ovarian cancer.

II. Determine the toxicity associated with intraperitoneal paclitaxel and topotecan in these
patients.

III. Examine the conjugate stability, pharmacokinetics, and biodistribution of 177Lu-CC49
given 48 hours after intraperitoneal paclitaxel.

IV. Determine the effects of IFN-A and intraperitoneal paclitaxel on 177Lu-CC49 tumor
localization and dosimetry estimates compared to a prior trial with 177Lu-CC49 alone.

V. Determine the MTD of yttrium Y 90 monoclonal antibody CC49 (90Y-CC49) when administered
with IFN-A and the dose of paclitaxel used at the MTD level of IFN-A, paclitaxel, and
177Lu-CC49.

VI. Monitor any antitumor effects of this treatment in these patients.

OUTLINE: This is a dose escalation study of paclitaxel, topotecan, lutetium LU 177
monoclonal antibody CC-49 (177Lu-CC49), and yttrium Y 90 monoclonal antibody CC49
(90Y-CC49).

Patients receive interferon alfa subcutaneously on days 1, 3, 5, and 7; paclitaxel
intraperitoneally (IP) on day 4 or topotecan IP on day 6; and 177Lu-CC49 IP on day 6.
Treatment continues every 6 weeks for 2 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of paclitaxel and
decreasing doses of 177Lu-CC49 until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose preceding that at which 3 of 5 patients experience dose limiting
toxicity. Once the MTD of paclitaxel is determined, the dose of 177Lu-CC49 is escalated.
Once the MTD of 177Lu-CC49 is determined, 90Y-CC49 is substituted. The MTD of 90Y-CC49 is
then determined when administered with paclitaxel. Topotecan is then substituted for
paclitaxel (administered with the MTD of 177Lu-CC49 and interferon alfa only) and escalated
until the MTD is determined. Patients are followed at 6 weeks and then every 3 months for 1
year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the ovary or papillary serous carcinoma of
extraovarian origin

- Recurrent or persistent following standard surgery and 1 or 2 chemotherapy regimens
(with or without paclitaxel), i.e.: persistent disease or progression after
chemotherapy with nodules less than the equivalent of 5 x 5 x 5 cm Recurrent
carcinoma (after primary or secondary chemotherapy) detected clinically either by
exam or rising CA 125 and with radiographic evidence of disease no greater than the
equivalent of 5 x 5 x 5 cm nodules

- Residual disease less than 5 x 5 x 5 cm following reassessment laparotomy

- Microscopic residual disease on reassessment laparotomy after chemotherapy

- Tumor TAG-72 positive by immunoperoxidase staining of original or current tumor
blocks

- At least 85% free flow of fluid in peritoneal cavity demonstrated by technetium-99m
scan or other imaging within 2 weeks prior to treatment

- No evidence of disease outside the peritoneal cavity other than retroperitoneal
lymphadenopathy

- No massive ascites

PATIENT CHARACTERISTICS:

- Age: 18 and over

- Performance status: ECOG 0-2

- WBC at least 3,500/mm3

- Platelet count at least 125,000/mm3

- Hemoglobin greater than 9 g/dL

- No nucleated RBC or significant teardrop RBC morphology

- Bilirubin less than 1.5 mg/dL

- AST/ALT less than 4 times normal

- Creatinine less than 2.0 mg/dL

- HIV negative

- Hepatitis B surface antigen negative

- No hypersensitivity to paclitaxel, polyoxethylated castor oil, or topotecan

- No other malignancy in past 5 years except basal cell skin carcinoma

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- At least 3 weeks since prior biologic therapy and recovered

- No prior monoclonal antibody therapy

- No concurrent immunotherapy

- No prior bone marrow or stem cell transplantation

- At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin)
and recovered

- No concurrent chemotherapy

- At least 3 weeks since prior radiotherapy and recovered

- No prior radiotherapy to the abdominal cavity

- No concurrent radiotherapy

- At least 3 weeks since prior major surgery and recovered

- No prior intraperitoneal therapy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ruby F. Meredith, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02240

NCT ID:

NCT00002734

Start Date:

March 1996

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294