Know Cancer

forgot password

Phase II Study of Weekly Carboplatin and Taxotere in Platinum Sensitive Relapsed Ovarian or Tubal or Primary Peritoneal Cancers

Phase 2
Not Enrolling
Platinum Sensitive Relapsed Ovarian Cancer

Thank you

Trial Information

Phase II Study of Weekly Carboplatin and Taxotere in Platinum Sensitive Relapsed Ovarian or Tubal or Primary Peritoneal Cancers

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.

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

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].

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (CR and PR) according to RECIST criteria.

Principal Investigator

mohammed salim, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Saskatoon Cancer Center


Canada: Health Canada

Study ID:




Start Date:

October 2003

Completion Date:

April 2007

Related Keywords:

  • Platinum Sensitive Relapsed Ovarian Cancer
  • Ovarian
  • Relapsed
  • Ovarian Neoplasms