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Weekly Carboplatin and Taxotere in Platinum Sensitive Relapsed Ovarian or Tubal or Primary Peritoneal Cancers

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ClinicalTrials.gov Identifier: NCT00247988
Recruitment Status : Terminated (Regulatory issues(trial temporarily suspended December 28, 2005. Permanently suspended January 19, 2007. Institutional Reveiw Board informed April 18, 2007)
First Posted : November 2, 2005
Last Update Posted : April 24, 2007
Sponsor:
Collaborator:
Sanofi
Information provided by:
University of Saskatchewan

Brief Summary:

Weekly carboplatin and taxotere will be tolerable and effective as second line treatment of platinum-sensitive ( >6 month treatment free interval) relapsed ovarian cancer

Primary efficacy parameter will be response rate (CR and PR) according to RECIST criteria.

Secondary endpoints will be duration of response, progression free survival and overall survival. Toxicity will also be evaluated.


Condition or disease Intervention/treatment Phase
Platinum Sensitive Relapsed Ovarian Cancer Drug: Weekly Taxotere with weekly carboplatin Phase 2

Detailed Description:

Ovarian cancer is the sixth most common malignancy in women, with estimated 2500 cases diagnosed in 2001, and 1500 deaths. Despite maximal cytoreductive therapy, followed normally by a taxane and carboplatin (or cisplatin) chemotherapy, most patients will relapse, and require chemotherapy in a palliative setting. The goal of this second line therapy is to prolong survival and to improve quality of life. This disease has been characterized as chronic, as many patients may eventually go on to respond to additional lines of therapy.

Response to second line therapy has been correlated to length of time since the end of the first line treatment (treatment free interval, TFI). Patients relapsing or progressing while on therapy are defined as platinum-refractory. In North America the norm is to label patients with a TFI of 6 months or less as platinum-resistant. A TFI of greater than 6 months would make a patient platinum-sensitive.

These platinum-sensitive patients are generally treated with single agent carboplatin or carboplatin and taxol by 3-weekly administration. The ICON-4 trial published in June 2003 compared single agent platinum to combination of platinum-taxol. Patients could have received one or both of these agents in the adjuvant setting. At a median follow-up of 42 months the absolute difference in 2-year survival was 7% [P=0.0004} in favor of the combination arm. Thus combination platinum-taxol is the present standard of care in platinum-sensitive relapsed ovarian cancer. Use of taxol is limited by persistent neuropathy in 20%.

Presently there is growing evidence in support of giving chemotherapy at shorter intervals at low-doses. Hypothetically, this allows less advancement of cancer cells through the cell cycle. Moreover weekly taxanes are associated with an anti-angiogenic effect- more so with taxotere than taxol in cell-lines.

Several randomized trials in breast cancer have shown the improved efficacy of weekly taxol over 3-weekly taxol. The neoadjuvant study showed an increase in pCR [complete response on pathologic evaluation] of 10%with weekly taxol. The adjuvant study with 2-weekly chemotherapy showed a 7% improvement in time-to-progression over 3-weekly chemotherapy.

In ovarian cancer- a Phase II study of weekly carboplatin (AUC-2) with taxol (80mg/m2/week) given on day 1,8,15 of 28 day cycles has shown a response rate of 100% [80% CR, 20% PR] in 21 platinum-sensitive patients- with either measurable or evaluable disease. Median duration of response was 11.7 months (95% CI- 8.0-18.5 months). 46% reported Grade I neuropathy, 1 patient had febrile neutropenia, and 32% had Grade 3 neutropenia.

Weekly administration of taxotere with carboplatin has been studied in a Phase I study. Maximum tolerated dose was Taxotere 35mg/m2 with carboplatin AUC-2. At this dose no Grade 3 or 4 cytopenias were seen. Nor were there significant neuropathies.

Our study plans to evaluate Taxotere 35mg/m2 with Carboplatin at AUC-2 given weekly. 3 weekly treatments will constitute one cycle. We expect to see equivalent response rates and equivalent or higher duration of responses with better toxicity profile.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Carboplatin and Taxotere in Platinum Sensitive Relapsed Ovarian or Tubal or Primary Peritoneal Cancers
Study Start Date : October 2003
Actual Study Completion Date : April 2007





Primary Outcome Measures :
  1. Response rate (CR and PR) according to RECIST criteria.

Secondary Outcome Measures :
  1. Duration of response, progression free survival and overall survival. Toxicity will also be evaluated.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must demonstrate their willingness to participate in the study (reliable and compliant for repeated treatments) and comply with its procedures by signing a written informed consent.
  2. Subjects must be 18 years of age or older.
  3. Subjects must have received a platinum regimen, with or without paclitaxel or cyclophosphamide, and have maintained a disease-free status for at least 6 months following the completion of first line therapy.
  4. Documented measurable or evaluable ovarian, tubal or primary peritoneal cancer by appropriate radiologic imaging (x-ray, or CT scan). Radiation therapy is allowed as long as not at the site of measurable disease. Recurrent disease based on elevated CA-125 alone is allowed, provided it meets the CA-125 progression definition.
  5. Subjects must have adequate hepatic, renal and marrow function (AST/ALT< 3UNL, creatinine<2UNL, ANC>2, HGB>90)
  6. Histologic diagnosis of ovarian, tubal or primary peritoneal cancer.
  7. Performance status: ECOG Score greater than or equal to 2.
  8. Subjects must have life expectancy of at least 6 months.
  9. Women of childbearing potential must have a negative pregnancy test at time of enrollment and must be using an acceptable method of birth- control during the study.

Exclusion Criteria:

  1. Female subjects who are pregnant, breast-feeding, or unwilling to use adequate contraception.
  2. Any other active primary tumor under treatment, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix;
  3. Two or more prior chemotherapy regimens for ovarian cancer
  4. Serious infection within one month of commencement of treatment.
  5. Patients with known brain metastasis. However baseline CT of the head is not a must.
  6. Patients with severe gastro-intestinal symptoms- e.g.- partial obstruction, bleeding or diarrhea.
  7. Patients with Grade 2 or higher neuropathy [NCI Common toxicity criteria].

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247988


Locations
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Canada, Saskatchewan
Saskatoon Cancer Center
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
University of Saskatchewan
Sanofi
Investigators
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Study Chair: mohammed salim, MD Saskatoon Cancer Center

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ClinicalTrials.gov Identifier: NCT00247988    
Other Study ID Numbers: XRP69761/6021
First Posted: November 2, 2005    Key Record Dates
Last Update Posted: April 24, 2007
Last Verified: April 2007
Keywords provided by University of Saskatchewan:
Ovarian
Relapsed
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Carboplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action