Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00004189 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : February 11, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific | Biological: filgrastim Drug: becatecarin Drug: cisplatin | Phase 1 |
OBJECTIVES:
I. Determine the maximum tolerated doses of a rebeccamycin analogue and cisplatin with or without filgrastim (G-CSF) in patients with advanced malignancies.
II. Determine the qualitative and quantitative toxicities of these regimens in these patients.
III. Determine if the pharmacokinetics of a rebeccamycin analogue are affected by cisplatin and if there are sequence dependent pharmacokinetic effects.
IV. Assess any antitumor effects of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study of a rebeccamycin analogue and cisplatin.
Part I (previously untreated or minimally pretreated patients): The first patient of each cohort receives cisplatin IV over 1 hour followed 2 hours later by a rebeccamycin analogue IV over 1 hour on day 1. The second patient in the same cohort receives the same drugs in the reverse order. The drug sequence for each additional patient within the same cohort is alternated with reference to the preceding patient. During each subsequent course, the study drugs are administered to each patient in the reverse order as compared to the prior course. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Dose escalation is initially performed without filgrastim (G-CSF). Cohorts of 4-6 patients receive escalating doses of a rebeccamycin analogue and cisplatin until the maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the highest dose at which less than 2 of 6 patients experience dose limiting toxicity (DLT). If 2 of the first 6 patients experience DLT, then dose escalation proceeds in combination with G-CSF treatment. Patients receive G-CSF subcutaneously daily beginning on day 2 and continuing until blood counts have recovered for 2 days or until approximately day 15. Cohorts of 4-6 patients receive escalating doses of a rebeccamycin analogue and cisplatin as above. The MTD is defined as above.
Part II (heavily pretreated patients): Heavily pretreated patients receive a rebeccamycin analogue and cisplatin starting at 2 dose levels preceding the MTD from part I.
Patients are followed for at least 30 days.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I and Pharmacokinetic Study of Sequences of NSC 655649 (Rebeccamycin Analogue) and Cisplatin Without and With Granulocyte Colony-Stimulating Factor Support Every 21 Days |
Study Start Date : | October 1999 |
Actual Primary Completion Date : | July 2003 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I
See detailed description.
|
Biological: filgrastim Drug: becatecarin Drug: cisplatin |

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically or cytologically proven advanced malignancy that is refractory to prior therapy or unlikely to benefit from standard therapy (e.g., chemotherapy, radiotherapy, and surgery)
-
Part I: Previously untreated OR minimally pretreated
-
Ineligible for part I and considered heavily pretreated if:
- Prior radiotherapy to wide ports involving the pelvis or at least 25% of bone marrow
- Greater than 6 courses of prior combination chemotherapy including alkylating agent
- Prior nitrosoureas or mitomycin
- Widespread bone metastases with bone marrow involvement by bone marrow biopsy (positive bilateral bone marrow biopsy for lymphoma patients)
-
- Part II: Heavily pretreated as defined above
-
- Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- SWOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Hemoglobin greater than 9 mg/dL
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 mg/dL
Renal:
- Creatinine less than 1.5 mg/dL
Cardiovascular:
- No uncontrolled hypertension
- No angina pectoris
- No clinically significant, multifocal, uncontrolled cardiac dysrhythmias
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active serious infection
- No clinically severe peripheral neuropathy (grade 1 or worse)
- No nonmalignant medical condition that would preclude compliance or increase risk of participation in study
- No hypersensitivity to E. coli derived drug preparations
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No other concurrent colony stimulating factors for prophylactic purposes
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks since prior nitrosoureas and mitomycin) and recovered
Endocrine therapy:
- No chronic oral corticosteroids
- No concurrent corticosteroids except as prophylactic antiemetic
Radiotherapy:
- At least 3 weeks since prior radiotherapy and recovered
Other:
- At least 1 month since prior investigational agent
- No prophylactic oral or IV antibiotics for neutropenia unless fever present
- No other concurrent anticancer treatment or investigational agent

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): NCT00004189
United States, Texas | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78229-3900 | |
Cancer Therapy and Research Center | |
San Antonio, Texas, United States, 78229 | |
St. Luke's Lutheran Hospital | |
San Antonio, Texas, United States, 78229 |
Study Chair: | Lisa Hammond, MD | The University of Texas Health Science Center at San Antonio |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004189 |
Other Study ID Numbers: |
CDR0000067430 UTHSC-IDD-98-34 SACI-IDD-98-34 NCI-T98-0069 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | February 11, 2013 |
Last Verified: | September 2003 |
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma small intestine lymphoma unspecified adult solid tumor, protocol specific stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma |
stage III adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma |
Lymphoma Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Cisplatin Antineoplastic Agents |