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Ovarian CancerPhase 1NCT00002734

Radiolabeled Monoclonal Antibody, Paclitaxel, and Interferon Alfa in Treating Patients With Recurrent Ovarian Cancer

A Phase 1 study testing recombinant interferon alfa, chemotherapy and paclitaxel in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase I trial to study the effectiveness of radiolabeled monoclonal antibody, paclitaxel, and interferon alfa in treating patients who have ovarian cancer. Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
recombinant interferon alfa, chemotherapy and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Mar 1996to Apr 2001
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294

Other trials in United States

About this study

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

Phase I trial to study the effectiveness of radiolabeled monoclonal antibody, paclitaxel, and interferon alfa in treating patients who have ovarian cancer. Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon may interfere with the growth of cancer cells. Combining monoclonal antibody, chemotherapy, and interferon alfa may kill more tumor cells.

Read the detailed description

OBJECTIVES:

  1. 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.

  1. 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.

Being tested
recombinant interferon alfa, chemotherapy, paclitaxel, topotecan hydrochloride, lutetium Lu 177 monoclonal antibody CC49
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant interferon alfaBiological

  • chemotherapyDrug

  • paclitaxelDrug

  • topotecan hydrochlorideDrug

  • lutetium Lu 177 monoclonal antibody CC49Radiation

  • yttrium Y 90 monoclonal antibody CC49Radiation

Study groups in NCT00002734
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: Biological: recombinant interferon alfa; Drug: chemotherapy; Drug: paclitaxel; Drug: topotecan hydrochloride; Radiation: lutetium Lu 177 monoclonal antibody CC49; Radiation: yttrium Y 90 monoclonal antibody CC49

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2004 (estimated)
  2. Study startMar 1996
  3. Primary completionApr 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002734
Sponsor's protocol ID
NCI-2012-02240
Other IDs
UAB-9502, NCI-B95-0003, CDR0000064633
Status last verified
Feb 2001
First submitted
1 Nov 1999
Last updated
5 Feb 2013
Results posted
No

Publications

  • Meredith R, Alvarez R, Khazaeli MB, et al.: Intraperitoneal radioimmunotherapy for refractory epithelial ovarian cancer with Lu-CC49. Minerva Biotechnologica 10: 100-107, 1998.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing recombinant interferon alfa, chemotherapy and paclitaxel in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002734, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2013.

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