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Ovarian CancerPhase 2NCT00003518

Paclitaxel Plus Gemcitabine in Treating Patients With Refractory Metastatic Germ Cell Tumors

A Phase 2 study testing gemcitabine hydrochloride and paclitaxel in people with Ovarian Cancer and Testicular Germ Cell Tumor, run by Eastern Cooperative Oncology Group at 19 sites in 2 countries.

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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus gemcitabine in treating patients with refractory metastatic germ cell… Read more about this study

Who is it for?
Ages 15 to 120 years
Conditions the study is for
Ovarian Cancer, Testicular Germ Cell Tumor
What is being tested?
gemcitabine hydrochloride and paclitaxel
How many people
44 participants
Where
19 sitesin 2 countries
Study dates
25 Jan 1999to Jul 2002
Phase
Phase 2
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 15 to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS: Histologically or serologically confirmed metastatic germ cell neoplasm (gonadal or extragonadal primary) that cannot be cured with either surgery or chemotherapy Seminomas, nonseminomas, or ovarian germ cell tumors allowed If histologically confirmed, requires one or more of the following: Metastatic lesions on chest x-ray or CT scan Rising serum HCG or AFP If only evidence of progressive disease, then two additional consecutive determinations must exhibit serologic progression Only eligible if alternative causes for increased serum levels are absent Failed initial cisplatin combination chemotherapy (generally bleomycin/etoposide/cisplatin, cisplatin/etoposide, cisplatin/vinblastine, or similar regimens) Failed and demonstrated progressive disease following the administration of at least one "salvage" regimen for advanced germ cell neoplasms Failed no more than three prior regimens defined as: 25% increase in the product of perpendicular diameters of measurable tumor masses during prior therapy, new lesions OR Increasing AFP or HCG Disease progression during initial induction chemotherapy or with primary mediastinal nonseminomatous germ cell tumors can be treated with paclitaxel plus gemcitabine as second-line therapy (initial salvage chemotherapy)

PATIENT CHARACTERISTICS: Age: 15 and over Performance status: ECOG 0-2 Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 4 times normal Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: No active uncontrolled infection Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since major surgery and recovered Other: At least 1 week since prior intravenous antibiotics No concurrent intravenous antibiotics

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States18 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois, 60611

  • Veterans Affairs Medical Center - Chicago (Lakeside)

    Chicago, Illinois, 60611

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80209-5031

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5265

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • Kimball Medical Center

    Lakewood, New Jersey, 08701

  • CCOP - Marshfield Medical Research and Education Foundation

    Marshfield, Wisconsin, 54449

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962-1956

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania, 19102-1192

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

Other trials in United States

South Africa1 site

  • Pretoria Academic Hospital

    Pretoria, 0001

Other trials in South Africa

About this study

Official title: Phase II Study of Paclitaxel Plus Gemcitabine in Refractory Germ Cell Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus gemcitabine in treating patients with refractory metastatic germ cell tumors that have not responded to surgery or chemotherapy.

Read the detailed description

OBJECTIVES: I. Evaluate the effect of gemcitabine plus paclitaxel on response rate, duration of remission, and survival in patients with refractory germ cell tumors. II. Evaluate the toxic effects of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1, 8, and 15 of each 4 week course. Treatment is repeated for a maximum of six courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.

PROJECTED ACCRUAL: Approximately 44 patients will be accrued over 19 months for this study.

Keywords
stage III malignant testicular germ cell tumor, recurrent malignant testicular germ cell tumor, stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor
Medical subject headings
Ovarian Neoplasms, Testicular Germ Cell Tumor, Testicular Neoplasms

What participants receive

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

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 start25 Jan 1999
  3. Primary completionJul 2002

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 2
Primary purpose
Treatment
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003518
Sponsor's protocol ID
CDR0000066562
Other IDs
E9897
Status last verified
Jun 2023
First submitted
1 Nov 1999
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No

Publications

  • Einhorn LH, Brames MJ, Juliar B, Williams SD. Phase II study of paclitaxel plus gemcitabine salvage chemotherapy for germ cell tumors after progression following high-dose chemotherapy with tandem transplant. J Clin Oncol. 2007 Feb 10;25(5):513-6. doi: 10.1200/JCO.2006.07.7271.

    PubMed 17290059

  • Hinton S, Catalano P, Einhorn LH, Loehrer PJ Sr, Kuzel T, Vaughn D, Wilding G. Phase II study of paclitaxel plus gemcitabine in refractory germ cell tumors (E9897): a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2002 Apr 1;20(7):1859-63. doi: 10.1200/JCO.2002.07.158.

    PubMed 11919245

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride and paclitaxel in people with Ovarian Cancer and Testicular Germ Cell Tumor, run by Eastern Cooperative Oncology Group at 19 sites in 2 countries.

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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, South Africa. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 NCT00003518, which also lists 2 linked publications.

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 22 Jun 2023.

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